Advanced or Metastatic Solid TumorsPhase 2NCT04003623
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
A Phase 2 study testing Pemigatinib in people with Advanced or Metastatic Solid Tumors and FGFR Mutations, run by Incyte Corporation at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, FGFR Mutations, FGFR Translocations
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Oct 2019to 12 Jun 2020
- Phase
- Phase 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
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective disease progression after at least 1 prior therapy.
- Not eligible or able to participate in any other Incyte-sponsored clinical trial.
Who cannot join
- Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
- Prior receipt of a selective FGFR inhibitor.
- Current evidence of clinically significant corneal or retinal disorder.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New Jersey Cancer Care and Blood Disorders
Belleville, New Jersey, 07109
TriHealth
Cincinnati, Ohio, 45220
Mary Crowley Cancer Center
Dallas, Texas, 75230
Compassionate Cancer Care Medical Group
Fountain Valley, California, 92708
FMH James M Stockman Cancer Institute
Frederick, Maryland, 21702
Hawaii Cancer Care
Honolulu, Hawaii, 96813
Oncology Consultants
Houston, Texas, 77030
Ocala Oncology Center
Ocala, Florida, 34474
Illinois Cancer Care
Peoria, Illinois, 61615
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Sanford Cancer Center
Sioux Falls, South Dakota, 51704
About this study
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.
- Being tested
- Pemigatinib
- Keywords
- Advanced solid tumor, metastatic solid tumor, FGFR inhibitor, FGFR mutation, FGFR translocation
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Not described Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Up to approximately 6 months
Secondary outcomes (5)
Progression-free Survival (PFS)
Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.
Measured: Up to approximately 6 months
Duration of Response (DOR)
Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
Measured: Up to approximately 6 months
Disease Control Rate (DCR)
Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
Measured: Up to approximately 6 months
Overall Survival (OS)
Defined as the time from first dose of study drug to death of any cause in each cohort.
Measured: Up to approximately 6 months
Number of Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start31 Oct 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Why it stopped: The study was closed due to lack of enrollment.
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.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 \[excluding kinase domain\]) but there is no difference in the treatment regimen between the cohorts.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003623
- Sponsor's protocol ID
- INCB 54828-MA-TA-208
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2019
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
- ClinicalTrials.gov ID
- NCT04003623
- Acronym / sponsor ID
- INCB 54828-MA-TA-208
- Keywords
- Advanced solid tumor, metastatic solid tumor, FGFR inhibitor, FGFR mutation, FGFR translocation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to lack of enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 21 Apr 2022
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 is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
| Arm | Type | Receives |
|---|---|---|
| Pemigatinib | Experimental | Drug: Pemigatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective disease progression after at least 1 prior therapy.
- Not eligible or able to participate in any other Incyte-sponsored clinical trial.
Key exclusion criteria (4 listed)
- Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
- Prior receipt of a selective FGFR inhibitor.
- Current evidence of clinically significant corneal or retinal disorder.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
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: INCB054828Pemigatinib administered orally once daily. | Drug | Pemigatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 6 months
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to approximately 6 months
Duration of Response (DOR)
Time frame: Up to approximately 6 months
Disease Control Rate (DCR)
Time frame: Up to approximately 6 months
Overall Survival (OS)
Time frame: Up to approximately 6 months
Number of Treatment-related Adverse Events
Time frame: Up to approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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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.
Incyte Medical Monitor study director
Incyte Corporation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib in people with Advanced or Metastatic Solid Tumors and FGFR Mutations, run by Incyte Corporation at 11 sites in United States.
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 5 inclusion and 4 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 phase mean?
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 21 Apr 2022). 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?
Objective Response Rate (ORR) (time frame: Up to approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.