Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alte⦠(NCT04096417) | Clinical Trial Compass
UnknownPhase 2
Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
United States14 participantsStarted 2020-08-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* COLOMATE Companion Trial Recommendation Form date of completion is =\< 30 days prior to registration
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable colorectal cancer (mCRC), based on documentation from local or outside review of pathology according to each site?s established institutional procedure
* Documentation of an activating genomic alteration(s) in FGFR1-3 (gain of function mutations, translocations, and amplifications allowed)
* Provide informed written consent
* 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)ā¦
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: 4.4 Months
Trial details
NCT IDNCT04096417
SponsorAcademic and Community Cancer Research United