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.
I. To assess overall response rate (ORR) of pemigatinib in patients with metastatic or
unresectable colorectal cancer harboring activating FGFR alterations.
I. To assess the clinical benefit rate (complete response + partial response + stable
disease) with pemigatinib.
II. To assess progression free survival (PFS) and overall survival (OS) with pemigatinib.
III. Assess changes in patient quality of life (QOL) as measured by the linear analogue
self-assessment (LASA) questionnaire.
IV. Assess the frequency and severity of adverse events.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess plasma pharmacodynamic biomarkers of response and resistance to therapy.
II. To explore any correlation between tissue and blood based biomarkers and clinical
Patients receive pemigatinib orally (PO) once daily (QD) on days 1-21. Treatment repeats
every 21 days for up to 35 cycles in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up every 3 months for 3 years
Metastatic Colorectal Carcinoma,
FGFR1 Gene Mutation,
FGFR2 Gene Mutation,
FGFR3 Gene Mutation,
FGFR1 Gene Amplification,
FGFR2 Gene Amplification,
Stage III Colorectal Cancer AJCC v8,
Stage IIIA Colorectal Cancer AJCC v8,
Stage IIIB Colorectal Cancer AJCC v8,
Stage IIIC Colorectal Cancer AJCC v8,
Stage IV Colorectal Cancer AJCC v8,
Stage IVA Colorectal Cancer AJCC v8,
Stage IVB Colorectal Cancer AJCC v8,
Stage IVC Colorectal Cancer AJCC v8,
Unresectable Colorectal Carcinoma,
FGFR1 Gene Translocation,
FGFR2 Gene Translocation,
FGFR3 Gene Amplification,
FGFR3 Gene Translocation
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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