Solid TumorPhase 2NCT06022289
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors
A Phase 2 study testing Pemigatinib in people with Solid Tumor and FGF Receptor Gene Mutation, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, FGF Receptor Gene Mutation, FGF Amplification
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years old; Gender unlimited
- Late stage, recurrent, or metastatic solid tumors confirmed by histology or cytology as unresectable by surgery.
- According to RECIST v1.1, there is at least one measurable lesion.
- Histological confirmation of FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.
- After standard treatment, the disease progresses, becomes intolerable, or standard treatment is ineffective, or there is no standard treatment plan.
- Has not previously used small molecule multi target inhibitors targeting the FGFR pathway (including arotinib, lenvatinib, sorafenib, apatinib, etc.).
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- ECOG physical fitness status is 0-1.
- Expected survival time>3 months.
- Sufficient organ function is required for the subject to meet the following laboratory indicators:
- In the past 14 days without using granulocyte colony stimulating factor, the absolute value of neutrophils (ANC) ≥ 1.5x10^9/L.
- Platelets ≥ 100 without blood transfusion in the past 14 days × 10^9/L.
- In the absence of blood transfusion or use of erythropoietin within the past 14 days, hemoglobin>9g/dL.
- Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN). Or total bilirubin>ULN but direct bilirubin ≤ ULN.
- 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 × ULN (ALT or AST ≤ 5 allowed for patients with liver metastasis) × ULN).
- 6) Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Fault formula) ≥ 50 ml/min.
- 7) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN. If the subject is undergoing anticoagulant therapy, as long as the PT is within the prescribed range of anticoagulant drugs, it is sufficient.
- For female subjects of childbearing age, they should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non reproductive age women are defined as those who have undergone at least one year of menopause or have undergone surgical sterilization or hysterectomy.
- If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Who cannot join
- Diagnosed within 5 years prior to the first administration as other malignant diseases outside of the current enrollment diagnosis (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection).
- Previously received selective FGFR inhibitor treatment.
- Those who have received any other study drug treatment or participated in intervention clinical studies within 28 days before the first administration. Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indications) within 28 days before the first use of the study drug.
- Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss).
- Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist. For brain metastasis subjects who have previously received treatment, if their condition is stable (there is no evidence of imaging progression within at least 4 weeks before the first administration of the trial treatment), repeated imaging examinations confirm no evidence of new brain metastasis or enlargement of existing brain metastasis lesions, and steroid treatment is not required at least 14 days before the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its clinical stability.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
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- The following laboratory parameters are abnormal:
- Serum phosphate>ULN.
- Serum calcium exceeds the normal range, or when serum albumin exceeds the normal range, the corrected calcium concentration of serum albumin exceeds the normal range.
- Potassium level<lower limit of normal value. Potassium levels can be corrected through supplementation during screening.
- Known history of human immunodeficiency virus (HIV) infection or confirmed positive immune test results.
- Severe infections with active or poorly controlled clinical conditions.
- Chest fluid, ascites, or pericardial effusion with obvious clinical symptoms that require drainage treatment.
- Individuals infected with acute or chronic active hepatitis B or hepatitis C, with hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 copies/ml. Hepatitis C virus (HCV) RNA>10^3 copies/ml. Hepatitis B surface antigen (HbsAg) and anti HCV antibody were positive at the same time. Those who have undergone nucleotides based antiviral treatment and fall below the above standards can be enrolled in the group.
- Clinically significant or uncontrolled heart diseases, including unstable angina pectoris, acute myocardial infarction occurring within 6 months prior to first administration, New York Heart Association Class III/IV congestive heart failure, and uncontrolled arrhythmia (allowing subjects with pacemakers or atrial fibrillation and good heart rate control).
- There are ECG changes or medical histories that researchers believe have clinical significance. Screening QTcF interval>480 ms, for subjects with indoor conduction block (QRS interval>120 ms), JTc interval can be used instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤ 340 ms).
- Uncontrolled hypertension, with systolic blood pressure>160 mmHg or diastolic blood pressure>100 mmHg after optimal medical treatment, hypertension crisis or history of hypertensive encephalopathy.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B grade or more severe cirrhosis.
- Has undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or is expected to require major surgery during the study treatment period.
- Toxicity and/or major surgical complications have not yet fully recovered before starting treatment.
- Pregnant or lactating women, or subjects who are expected to conceive or give birth during the study period from screening visits to completion of safety follow-up visits (male subjects up to 90 days after last administration).
- Received radiotherapy within 4 weeks prior to the first administration of the study drug. The radiation related toxicity of the subject must have fully recovered, and corticosteroid treatment is not required. It is confirmed that radiation pneumonia has been ruled out. For palliative radiotherapy for non-CNS diseases, a 2-week washout period is allowed.
- Have a history of systemic electrolyte metabolism imbalance caused by calcium and phosphorus metabolism disorders or accompanied by soft tissue ectopic calcification (excluding skin, kidney, tendon, or vascular calcification caused by injuries, diseases, and advanced age without systemic electrolyte metabolism imbalance).
- Corneal or retinal diseases confirmed to have clinical significance through ophthalmic examination.
- Any potent CYP3A4 inhibitor (see Appendix A for details) or inducer has been used within 14 days or 5 half-lives before the first administration of the study drug, whichever is shorter. Allow external use of ketoconazole.
- It is known that there is an allergic reaction to Pemigatinib or its research drug excipients.
- Unable or unwilling to swallow Pemigatinib or suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion.
- The subject has a history of vitamin D deficiency and needs to supplement vitamin D beyond physiological levels (excluding vitamin D dietary supplements).
- Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to increased risk of study participation or drug administration, or interference with the interpretation of study results, and the inclusion of patients as ineligible to participate in this study based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Haitao Wang, Ph.D, +86-022-88326385, peterrock2000@126.com
Jinhuan Wang, Ph.D, +86-18602249531, wjhhappy2008@163.com
About this study
Official title: Safety and Efficacy of Pemigatinib in the Treatment of Advanced Pan Solid Tumors With FGF/FGFR Alterations: An Open, Single-arm, Prospective Phase II Trial
The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.
Read the detailed description
This study is a prospective, single arm, phase II clinical study. Patients with advanced solid tumors who had previously failed standard treatment and had FGFR1-3 alterations were selected and included in this study after signing the informed consent form and meeting the inclusion criteria. The patient will receive oral treatment with pemitinib (13.5 mg QD, administered for 2 weeks/discontinued for 1 week). Before assessment for eligibility, patients were prescreened centrally for FGF/FGFR status using massively parallel DNA sequencing.Patients who already had an FGF/FGFR status report based on local assessment (Clinical Laboratory Improvement Amendments [CLIA]-certifed) or an existing MTB approved report were also included. The subjects will continue treatment until disease progression or intolerable toxicity occurs. During the treatment process, clinical tumor imaging evaluation was conducted according to RECIST v1.1, every 6 weeks (± 7 days), and every 9 weeks (± 7 days) after 48 weeks. Use NCI-CTCAE 5.0 for safety assessment.
- Conditions
- Solid Tumor, FGF Receptor Gene Mutation, FGF Amplification, FGF Receptor Gene Family Rearrangement, FGF Receptor Gene Translocation
- Being tested
- Pemigatinib
- Keywords
- Solid Tumor, FGFR, Pemigatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB05482
Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy or combination therapy based on Pemigatinib | Experimental | Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status. Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival 2/Progression-free Survival 1(PFS2/PFS1)
The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.
Measured: Through study completion, an expected average of 1 year.
Secondary outcomes (6)
Objective Response Rate (ORR)
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.
Measured: Through study completion, an expected average of 1 year.
Progression-free Survival (PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
Measured: The last subject completes at least 24 weeks of follow-up (or disease progression).
Disease control rate (DCR)
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.
Measured: Through study completion, an expected average of 1 year.
Overall survival(OS)
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
Measured: Through study completion, an expected average of 2 years.
Duration of Response(DOR)
Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Measured: Through study completion, an expected average of 1 year.
Adverse events(AEs）
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.
Measured: Through study completion, an expected average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HaiTao Wang, Ph.D, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022289
- Sponsor's protocol ID
- Pemigatinib for Pan-cancer
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pemigatinib in the Treatment of Advanced Pan Solid Tumors With FGF/FGFR Alterations: An Open, Single-arm, Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT06022289
- Acronym / sponsor ID
- Pemigatinib for Pan-cancer
- Conditions
- Solid Tumor, FGF Receptor Gene Mutation, FGF Amplification, FGF Receptor Gene Family Rearrangement, FGF Receptor Gene Translocation
- Keywords
- Solid Tumor, FGFR, Pemigatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
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 clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.
Detailed description
This study is a prospective, single arm, phase II clinical study. Patients with advanced solid tumors who had previously failed standard treatment and had FGFR1-3 alterations were selected and included in this study after signing the informed consent form and meeting the inclusion criteria. The patient will receive oral treatment with pemitinib (13.5 mg QD, administered for 2 weeks/discontinued for 1 week). Before assessment for eligibility, patients were prescreened centrally for FGF/FGFR status using massively parallel DNA sequencing.Patients who already had an FGF/FGFR status report based on local assessment (Clinical Laboratory Improvement Amendments [CLIA]-certifed) or an existing MTB approved report were also included. The subjects will continue treatment until disease progression or intolerable toxicity occurs. During the treatment process, clinical tumor imaging evaluation was conducted according to RECIST v1.1, every 6 weeks (± 7 days), and every 9 weeks (± 7 days) after 48 weeks. Use NCI-CTCAE 5.0 for safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy or combination therapy based on Pemigatinib | Experimental | Drug: PemigatinibPemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years old; Gender unlimited
- Late stage, recurrent, or metastatic solid tumors confirmed by histology or cytology as unresectable by surgery.
- According to RECIST v1.1, there is at least one measurable lesion.
- Histological confirmation of FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.
- After standard treatment, the disease progresses, becomes intolerable, or standard treatment is ineffective, or there is no standard treatment plan.
Key exclusion criteria (29 listed)
- Diagnosed within 5 years prior to the first administration as other malignant diseases outside of the current enrollment diagnosis (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection).
- Previously received selective FGFR inhibitor treatment.
- Those who have received any other study drug treatment or participated in intervention clinical studies within 28 days before the first administration. Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indications) within 28 days before the first use of the study drug.
- Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss).
- Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist. For brain metastasis subjects who have previously received treatment, if their condition is stable (there is no evidence of imaging progression within at least 4 weeks before the first administration of the trial treatment), repeated imaging examinations confirm no evidence of new brain metastasis or enlargement of existing brain metastasis lesions, and steroid treatment is not required at least 14 days before the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its clinical stability.
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: INCB05482Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status. | Drug | Monotherapy or combination therapy based on Pemigatinib |
Primary outcome
Progression-free Survival 2/Progression-free Survival 1(PFS2/PFS1)
Time frame: Through study completion, an expected average of 1 year.
The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Through study completion, an expected average of 1 year.
Progression-free Survival (PFS)
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression).
Disease control rate (DCR)
Time frame: Through study completion, an expected average of 1 year.
Overall survival(OS)
Time frame: Through study completion, an expected average of 2 years.
Duration of Response(DOR)
Time frame: Through study completion, an expected average of 1 year.
Adverse events(AEs）
Time frame: Through study completion, an expected average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
HaiTao Wang, Ph.D principal investigator
Tianjin Medical University Second Hospital
1 site 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 Solid Tumor and FGF Receptor Gene Mutation, run by Tianjin Medical University Second Hospital at 1 site in China.
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 18 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HaiTao Wang, Ph.D (+86-022-88326385, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival 2/Progression-free Survival 1(PFS2/PFS1) (time frame: Through study completion, an expected average of 1 year.). 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 1 Sep 2023.