Lung CancerPhase 1/2NCT02393248
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
A Phase 1/2 study testing Pemigatinib, Gemcitabine and Pembrolizumab in people with Lung Cancer and Solid Tumor, run by Incyte Corporation at 20 sites in 2 countries.
Trial summary
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Solid Tumor, Gastric Cancer
- What is being tested?
- Pemigatinib, Gemcitabine and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 27 Feb 2015to 17 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, age 18 years or older on day of signing consent
- Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
- Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
- Life expectancy > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status:
- Part 1: 0 or 1
- Part 2 and 3: 0, 1, or 2
Who cannot join
- Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
- Prior receipt of a selective FGFR inhibitor
- History of a calcium/phosphate homeostasis disorder
- History and/or current evidence of ectopic mineralization/calcification
- Current evidence of corneal disorder/keratopathy
- Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
- Prior radiotherapy within 2 weeks of study treatment
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35205
Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210
Mary Crowley Cancer Research Ctr
Dallas, Texas, 75230
Duke University Medical Center
Durham, North Carolina, 27710
Greenville Health System Cancer Institute
Greenville, South Carolina, 29605
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Md Anderson Cancer Center
Houston, Texas, 77030
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Yale Cancer Center
New Haven, Connecticut, 06510
Northwell Health - Monter Cancer Center
New Hyde Park, New York, 11042
Hematology Oncology Associates of the Tr
Port Saint Lucie, Florida, 34952
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
Baylor Scott & White Health
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10461
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Cedars-Sinai Medical Center
West Hollywood, California, 90048
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).
- Conditions
- Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer, Endometrial Cancer, Multiple Myeloma
- Being tested
- Pemigatinib, Gemcitabine, Pembrolizumab, Docetaxel, Trastuzumab
- Keywords
- alterations in FGF or FGFR, squamous non-small cell lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma, MPN
- Medical subject headings
- Lung Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Multiple Myeloma, Myeloproliferative Disorders, Breast Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
GemcitabineDrug
PembrolizumabDrug
DocetaxelDrug
TrastuzumabDrug
RetifanlimabDrug
Also called INCMGA00012
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Intermittent pemigatinib 1/2/4 mg QD | Experimental | Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 1: Intermittent pemigatinib 6 mg QD | Experimental | Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 1: Intermittent pemigatinib 9 mg QD | Experimental | Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 1: Intermittent pemigatinib 13.5 mg QD | Experimental | Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 1: Intermittent pemigatinib 20 mg QD | Experimental | Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 1: Continuous pemigatinib 9 mg QD | Experimental | Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 1: Continuous pemigatinib 13.5 mg QD | Experimental | Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 1: Continuous pemigatinib 20 mg QD | Experimental | Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 1: Continuous pemigatinib 7.5 mg BID | Experimental | Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 1: Continuous pemigatinib 10 mg BID | Experimental | Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 2: Intermittent pemigatinib 9 mg QD | Experimental | Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 2: Intermittent pemigatinib 13.5 mg QD | Experimental | Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Receives: Drug: Pemigatinib |
| Part 2: Continuous pemigatinib 9 mg QD | Experimental | Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 2: Continuous pemigatinib 13.5 mg QD | Experimental | Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 2: Continuous pemigatinib 20 mg QD | Experimental | Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib |
| Part 3: Gem/Cis/intermittent pemigatinib 9 mg | Experimental | Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. Receives: Drug: Pemigatinib; Drug: Gemcitabine; Drug: Cisplatin |
| Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg | Experimental | Participants received gemcitabine intravenously starting at 1000 mg/m^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. Receives: Drug: Pemigatinib; Drug: Gemcitabine; Drug: Cisplatin |
| Part 3: Tras/intermittent pemigatinib 13.5 mg | Experimental | Trastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab. Receives: Drug: Pemigatinib; Drug: Trastuzumab |
| Part 3: Doc/intermittent pemigatinib 13.5 mg | Experimental | Participants received docetaxel (Doc) intravenously starting at 75 mg/m^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel. Receives: Drug: Pemigatinib; Drug: Docetaxel |
| Part 3: Pem/intermittent pemigatinib 9 mg | Experimental | Participants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. Receives: Drug: Pemigatinib; Drug: Pembrolizumab |
| Part 3: Pem/intermittent pemigatinib 13.5 mg | Experimental | Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. Receives: Drug: Pemigatinib; Drug: Pembrolizumab |
| Part 3: Pem/continuous pemigatinib 13.5 mg | Experimental | Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. Receives: Drug: Pemigatinib; Drug: Pembrolizumab |
| Part 3: Ref/continuous pemigatinib 9 mg | Experimental | Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib; Drug: Retifanlimab |
| Part 3: Ref/continuous pemigatinib 13.5 mg | Experimental | Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib; Drug: Retifanlimab |
| Part 3: Ref/continuous pemigatinib 20 mg | Experimental | Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. Receives: Drug: Pemigatinib; Drug: Retifanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Measured: up to 763 days
Part 3: Number of Participants With Any TEAE
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Measured: up to 869 days
E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
E0 was defined as the Baseline serum concentration of phosphate.
Measured: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Measured: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Measured: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
Serum phosphate concentration was assessed throughout Parts 1 and 2.
Measured: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Secondary outcomes (33)
Part 2: Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 126 days
Part 3: ORR
ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 203 days
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Cmax was defined as the maximum observed plasma concentration.
Measured: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
tmax was defined as the time to the maximum observed plasma concentration.
Measured: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Measured: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Measured: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Cmax was defined as the maximum observed plasma concentration.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
tmax was defined as the time to the maximum observed plasma concentration.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
CL/F was defined as the apparent oral dose clearance.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Vz/F was defined as the apparent volume of distribution.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Measured: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Cmax was defined as the maximum observed plasma concentration.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
tmax was defined as the time to the maximum observed plasma concentration.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
CL/F was defined as the apparent oral dose clearance.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Vz/F was defined as the apparent volume of distribution.
Measured: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Cmax was defined as the maximum observed plasma concentration.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
tmax was defined as the time to the maximum observed plasma concentration.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Cmax was defined as the maximum observed plasma concentration.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
tmax was defined as the time to the maximum observed plasma concentration.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
CL/F was defined as the apparent oral dose clearance.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Vz/F was defined as the apparent volume of distribution.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Measured: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start27 Feb 2015
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Féliz, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393248
- Sponsor's protocol ID
- INCB 54828-101
- Status last verified
- Dec 2022
- First submitted
- 30 Jan 2015
- Last updated
- 6 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Expanded access
- Available
Publications
Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.
PubMed 35176457Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.
PubMed 34951522
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
- ClinicalTrials.gov ID
- NCT02393248
- Acronym / sponsor ID
- INCB 54828-101
- Conditions
- Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer, Endometrial Cancer, Multiple Myeloma
- Keywords
- alterations in FGF or FGFR, squamous non-small cell lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma, MPN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 6 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 25
| Arm | Type | Receives |
|---|---|---|
| Part 1: Intermittent pemigatinib 1/2/4 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 1: Intermittent pemigatinib 6 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 1: Intermittent pemigatinib 9 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 1: Intermittent pemigatinib 13.5 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 1: Intermittent pemigatinib 20 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 1: Continuous pemigatinib 9 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 1: Continuous pemigatinib 13.5 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 1: Continuous pemigatinib 20 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 1: Continuous pemigatinib 7.5 mg BID | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle. |
| Part 1: Continuous pemigatinib 10 mg BID | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle. |
| Part 2: Intermittent pemigatinib 9 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 2: Intermittent pemigatinib 13.5 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. |
| Part 2: Continuous pemigatinib 9 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 2: Continuous pemigatinib 13.5 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 2: Continuous pemigatinib 20 mg QD | Experimental | Drug: PemigatinibParticipants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 3: Gem/Cis/intermittent pemigatinib 9 mg | Experimental | Drug: Pemigatinib, Drug: Gemcitabine, Drug: CisplatinParticipants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. |
| Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: Gemcitabine, Drug: CisplatinParticipants received gemcitabine intravenously starting at 1000 mg/m^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. |
| Part 3: Tras/intermittent pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: TrastuzumabTrastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab. |
| Part 3: Doc/intermittent pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: DocetaxelParticipants received docetaxel (Doc) intravenously starting at 75 mg/m^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel. |
| Part 3: Pem/intermittent pemigatinib 9 mg | Experimental | Drug: Pemigatinib, Drug: PembrolizumabParticipants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. |
| Part 3: Pem/intermittent pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: PembrolizumabParticipants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. |
| Part 3: Pem/continuous pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: PembrolizumabParticipants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. |
| Part 3: Ref/continuous pemigatinib 9 mg | Experimental | Drug: Pemigatinib, Drug: RetifanlimabRetifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 3: Ref/continuous pemigatinib 13.5 mg | Experimental | Drug: Pemigatinib, Drug: RetifanlimabRetifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. |
| Part 3: Ref/continuous pemigatinib 20 mg | Experimental | Drug: Pemigatinib, Drug: RetifanlimabRetifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, age 18 years or older on day of signing consent
- Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
- Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
- Life expectancy > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status:
Key exclusion criteria (7 listed)
- Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
- Prior receipt of a selective FGFR inhibitor
- History of a calcium/phosphate homeostasis disorder
- History and/or current evidence of ectopic mineralization/calcification
- Current evidence of corneal disorder/keratopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinibAlso: INCB054828 | Drug | Part 1: Continuous pemigatinib 10 mg BID, Part 1: Continuous pemigatinib 13.5 mg QD, Part 1: Continuous pemigatinib 20 mg QD, Part 1: Continuous pemigatinib 7.5 mg BID, Part 1: Continuous pemigatinib 9 mg QD, Part 1: Intermittent pemigatinib 1/2/4 mg QD, Part 1: Intermittent pemigatinib 13.5 mg QD, Part 1: Intermittent pemigatinib 20 mg QD, Part 1: Intermittent pemigatinib 6 mg QD, Part 1: Intermittent pemigatinib 9 mg QD, Part 2: Continuous pemigatinib 13.5 mg QD, Part 2: Continuous pemigatinib 20 mg QD, Part 2: Continuous pemigatinib 9 mg QD, Part 2: Intermittent pemigatinib 13.5 mg QD, Part 2: Intermittent pemigatinib 9 mg QD, Part 3: Doc/intermittent pemigatinib 13.5 mg, Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg, Part 3: Gem/Cis/intermittent pemigatinib 9 mg, Part 3: Pem/continuous pemigatinib 13.5 mg, Part 3: Pem/intermittent pemigatinib 13.5 mg, Part 3: Pem/intermittent pemigatinib 9 mg, Part 3: Ref/continuous pemigatinib 13.5 mg, Part 3: Ref/continuous pemigatinib 20 mg, Part 3: Ref/continuous pemigatinib 9 mg, Part 3: Tras/intermittent pemigatinib 13.5 mg |
| Gemcitabine | Drug | Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg, Part 3: Gem/Cis/intermittent pemigatinib 9 mg |
| Pembrolizumab | Drug | Part 3: Pem/continuous pemigatinib 13.5 mg, Part 3: Pem/intermittent pemigatinib 13.5 mg, Part 3: Pem/intermittent pemigatinib 9 mg |
| Docetaxel | Drug | Part 3: Doc/intermittent pemigatinib 13.5 mg |
| Trastuzumab | Drug | Part 3: Tras/intermittent pemigatinib 13.5 mg |
| RetifanlimabAlso: INCMGA00012 | Drug | Part 3: Ref/continuous pemigatinib 13.5 mg, Part 3: Ref/continuous pemigatinib 20 mg, Part 3: Ref/continuous pemigatinib 9 mg |
| Cisplatin | Drug | Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg, Part 3: Gem/Cis/intermittent pemigatinib 9 mg |
Primary outcome
Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 763 days
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Part 3: Number of Participants With Any TEAE
Time frame: up to 869 days
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Time frame: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
E0 was defined as the Baseline serum concentration of phosphate.
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Time frame: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Time frame: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
Time frame: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Serum phosphate concentration was assessed throughout Parts 1 and 2.
33 secondary outcomes
Part 2: Overall Response Rate (ORR)
Time frame: up to 126 days
Part 3: ORR
Time frame: up to 203 days
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Time frame: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Time frame: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Time frame: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Time frame: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Time frame: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Time frame: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35176457Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.
- Derived from this study: PubMed 34951522Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Féliz, MD study director
Incyte Corporation
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pemigatinib, Gemcitabine and Pembrolizumab in people with Lung Cancer and Solid Tumor, run by Incyte Corporation at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 763 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393248, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.