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

NCT04096417 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-02-21

Study results available
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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.

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

DRUG

Pemigatinib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Kristen K Ciombor · Academic and Community Cancer Research United

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2022-05-13
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096417 on ClinicalTrials.gov