RecruitingPhase 1Phase 2NCT05700656

Galunisertib Combined With Capecitabine in Advanced CRC With PM

Phase I/II Study With Galunisertib Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer With Peritoneal Metastases

Sponsor

The Netherlands Cancer Institute

Enrollment

31 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Peritoneal Carcinomatosis Colorectal Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether galunisertib — a drug that blocks a signaling pathway that helps tumors evade the immune system — combined with capecitabine (an oral chemotherapy) can treat advanced colorectal cancer that has spread to the lining of the abdomen (peritoneal metastases) with no remaining standard treatment options. **You may be eligible if...** - You are 18 or older with colorectal cancer confirmed to have spread to the peritoneum - You have tried all available standard treatments and your cancer has progressed - You are in good performance status (WHO score 0 or 1) - You are willing to provide blood samples and tumor biopsies **You may NOT be eligible if...** - You have serious heart problems (certain heart rhythm or function issues) - You have severe kidney or liver dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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