Galunisertib Combined With Capecitabine in Advanced CRC With PM
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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);
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.
Trial design
Treatments tested in this trial
- Galunisertib plus capecitabine
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Amsterdam UMC
Collaborator
Source ClinicalTrials.gov