Spots Global Cancer Trial Database for Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVE: I. To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring activating FGFR alterations. SECONDARY OBJECTIVES: 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 outcomes. OUTLINE: 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 toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years after registration.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial