NCT04096417

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients With Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FGFR1 Gene Amplification
• FGFR1 Gene Mutation
• FGFR1 Gene Translocation
• FGFR2 Gene Amplification
• FGFR2 Gene Mutation
• FGFR2 Gene Translocation
• FGFR3 Gene Amplification
• FGFR3 Gene Mutation
• FGFR3 Gene Translocation
• Metastatic Colorectal Carcinoma
• 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

Interventions

Type	Name	Description
DRUG	Pemigatinib	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2020-08-31
• Primary completion: 2022-05-13
• Completion: 2025-12-01
• First posted: 2019-09-19
• Last updated: 2024-02-21
• Results posted: 2024-02-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study