Pemigatinib for Colorectal Cancer
Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Academic and Community Cancer Research United
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 1 JurisdictionThis treatment is already approved in other countries
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot use certain medications like potent CYP3A4 inhibitors or inducers within 14 days before joining the trial.
Is pemigatinib safe for humans?
Pemigatinib has been studied in patients with advanced cancers, and common side effects include high phosphate levels in the blood, hair loss, diarrhea, and nausea. Serious risks include eye problems and high phosphate levels, but overall, it has shown an acceptable safety profile in clinical trials.12345
What is the purpose of this trial?
This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
Research Team
KK
Kristen K Ciombor
Principal Investigator
Academic and Community Cancer Research United
Eligibility Criteria
This trial is for adults with metastatic or unresectable colorectal cancer that has specific FGFR gene alterations. Participants must have tried and not responded to standard treatments, including chemotherapy and targeted therapies like anti-VEGF and anti-EGFR if applicable. They should be in a relatively stable condition (ECOG performance status of 0, 1, or 2) with adequate organ function and no significant heart issues, eye disorders, or other serious health problems.Inclusion Criteria
Patient must have received and progressed on, or be intolerant to, each of the following treatments for mCRC (or have contraindication to these treatments): Fluoropyrimidine, Oxaliplatin, Irinotecan, Anti-VEGF (vascular endothelial growth factor) monoclonal antibody, if eligible for this therapy, Anti-EGFR (epidermal growth factor receptor) monoclonal antibody, if eligible for this therapy, Measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2, Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to registration), Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to registration), Hemoglobin >= 9.0 g/dL (obtained =< 28 days prior to registration), Total bilirubin =< 1.5x upper limit of normal (ULN), or =< 2.5x ULN if patient has Gilbert syndrome or disease involving the liver (obtained =< 28 days prior to registration), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5x ULN (or =< 5x ULN in presence of suspected liver metastases) (obtained =< 28 days prior to registration), Serum phosphate < institutional ULN (obtained =< 28 days prior to registration), Serum calcium within institutional normal range, or serum albumin-corrected calcium within institutional normal range (if serum albumin is outside of the institutional normal range) (obtained =< 28 days prior to registration), Potassium levels > institutional lower limit of normal (supplementation can be used to correct potassium level during screening) (obtained =< 28 days prior to registration), Serum creatinine =< 1.5x ULN, or calculated creatinine clearance > 30 mL/min using the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained =< 28 days prior to registration), Corrected QT interval (QTc) by Fridericia's method (QTcF) assessed by electrocardiogram (ECG) completed =< 28 days prior to registration, and resulted as: QTcF =< 450 msec in men, or QTcF =< 470 msec in women, Negative serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only, Willing to provide tissue and blood samples for correlative research purposes, Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research
My cancer has a specific genetic change in the FGFR1-3 genes.
Registered to Colorectal and Liquid Biopsy Molecularly Assigned Therapy (COLOMATE) Academic and Community Cancer Research United (ACCRU)-GI-1611 and COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be screened for a COLOMATE companion trial
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pemigatinib orally once daily on days 1-21, with treatment repeating every 21 days for up to 35 cycles
Approximately 24 months
Regular visits every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
36 months
Follow-up every 3 months
Treatment Details
Interventions
- Pemigatinib
Trial Overview The trial is testing the effectiveness of Pemigatinib—a drug designed to block FGFR which tumors need to grow—in patients whose colorectal cancer has spread and cannot be surgically removed. It's a phase II study focusing on how well this treatment works when traditional options fail due to specific genetic changes in the tumor.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (pemigatinib)Experimental Treatment2 Interventions
Patients receive pemigatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pemigatinib is already approved in United States for the following indications:
Approved in United States as Pemazyre for:
- Unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
- Relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
Trials
54
Recruited
4,900+
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+
Findings from Research
Pemigatinib (PEMAZYRE™) is the first targeted therapy approved in the USA for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma that has a FGFR2 fusion or rearrangement, highlighting its significance in treating this challenging cancer.
The recommended dosage is 13.5 mg once daily for 14 days in a 21-day cycle, and it is currently being evaluated for use in other FGFR-driven cancers, indicating its potential broader application beyond cholangiocarcinoma.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pemigatinib: First Approval.Hoy, SM.[2021]
In a phase I trial involving 12 Chinese patients with advanced solid tumors, pemigatinib showed acceptable safety and tolerability, with 25% of patients experiencing grade 3 or higher adverse events.
The drug demonstrated preliminary efficacy, with partial responses observed in two patients with specific FGFR mutations, indicating its potential as a targeted therapy for tumors with FGF/FGFR alterations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial.Deng, T., Zhang, L., Shi, Y., et al.[2023]
Pemigatinib is an effective oral treatment for advanced/metastatic cholangiocarcinoma (CCA) with FGFR2 alterations, showing a favorable benefit-risk profile at a dose of 13.5 mg once daily in 21-day cycles based on a refined pharmacokinetic model from 467 participants.
The study found that pemigatinib exposure is linked to both efficacy and safety, with a bell-shaped relationship between drug levels and response rates, as well as treatment-emergent adverse events like decreased appetite and nausea, although these relationships were not clinically significant.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Population pharmacokinetic and exposure-response analyses of pemigatinib in patients with advanced solid tumors including cholangiocarcinoma.Gong, X., Akil, A., Ndi, A., et al.[2023]
References
Pemigatinib: First Approval. [2021]
Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial. [2023]
Population pharmacokinetic and exposure-response analyses of pemigatinib in patients with advanced solid tumors including cholangiocarcinoma. [2023]
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement. [2023]
A drug safety evaluation of pemigatinib for advanced cholangiocarcinoma. [2023]
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