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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological or cytological proof of CRC with at least confirmed peritoneal metastases (presence of additional extraperitoneal metastases is allowed);

• Disease progression or relapse upon treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination with other anti-cancer drugs, with no treatment options at time of inclusion (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);

• Age ≥ 18 years;

• Able and willing to give written informed consent and informed consent form must have been signed before start of the trial;

• WHO performance status of ≤1;

• Able and willing to undergo blood sampling for PK analysis;

• Able and willing to undergo tumor biopsy before start, during treatment and at the end of treatment;

• Life expectancy \> 3 months allowing adequate follow up of toxicity and anti-tumor activity;

• Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);

⁃ Minimal acceptable safety laboratory values

∙ ANC of ≥1.5 x 109/L

‣ Platelet count of ≥100 x 109/L

‣ Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT \< 5 x ULN in patients with liver metastases

‣ Renal function as defined by serum creatinine ≤ 1.5 x ULN

‣ Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);

⁃ Negative pregnancy test (urine or serum) for female patients with childbearing potential.

⁃ Able and willing to swallow tablets.

Locations
Other Locations
Netherlands
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Netherlands Cancer Institute
RECRUITING
Amsterdam
Contact Information
Primary
Alaa Embaby, MD
a.embaby@nki.nl
0031205129111
Time Frame
Start Date: 2023-07-28
Estimated Completion Date: 2025-04
Participants
Target number of participants: 31
Treatments
Experimental: Galunisertib plus capecitabine
Galunisertib 150 mg BID for 14 days in a 28-day cycle plus capecitabine 1000 mg/m2 BID for 14 days in a 28-day cycle
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute
Collaborators: Amsterdam UMC

This content was sourced from clinicaltrials.gov