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Galunisertib Combined With Capecitabine in Advanced CRC With PM

NCT05700656 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-07-22

No results posted yet for this study

Summary

This is a two-center open-label non-randomized proof of principle study consisting of a dose-finding part (phase I) and phase II study with Simon two-stage design investigating the anti-tumor activity of the combination of capecitabine and galunisertib in patients with colorectal cancer with peritoneal metastases.

Conditions

  • Colorectal Cancer Metastatic
  • Peritoneal Carcinomatosis

Interventions

DRUG

Galunisertib plus capecitabine

Combination therapy with galunisertib plus capecitabine

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Netherlands

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 NCT05700656 on ClinicalTrials.gov