Galunisertib Combined With Capecitabine in Advanced CRC With PM (NCT05700656) | Clinical Trial Compass
RecruitingPhase 1/2
Galunisertib Combined With Capecitabine in Advanced CRC With PM
Netherlands31 participantsStarted 2023-07-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
Exclusion criteria
✕. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment and/or radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed; except radiotherapy focused on the liver;
✕. Known or suspected complete or partial dihydropyrimidine dehydrogenase deficiency (Mutant for DPD\*2A genotype, 1236G\>A genotype, 1679T\>G genotype and 2846A\>T genotype);
What they're measuring
1
Number of participants with treatment-related adverse events according to CTCAE v5.0, dose limiting toxicities
Timeframe: 28 days
2
Objective response rate (ORR)
Timeframe: through study completion, an average of 6 months per patient
✕. Symptomatic or untreated leptomeningeal disease;
✕. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g.
✕. History of cardiac disease, including myocardial infarction within 6 months before first dose of study medication, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart;
✕. Treatment with CYP3A4 inducers or inhibitors and/or concomitant treatment with CYP2C9 substrates with narrow therapeutic window, including but not limited to vitamin K antagonizing anticoagulants (e.g. acenocoumarol, phenprocoumon and warfarin) and phenytoin is not allowed;
✕. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral galunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, major small bowel surgery);