OncoMatch/Clinical Trials/NCT05700656
Galunisertib Combined With Capecitabine in Advanced CRC With PM
Is NCT05700656 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Galunisertib plus capecitabine for colorectal cancer metastatic.
Treatment: Galunisertib plus capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Ovarian Cancer
Biomarker criteria
Excluded: DPYD DPD*2A genotype
Mutant for DPD*2A genotype
Excluded: DPYD 1236G>A genotype
1236G>A genotype
Excluded: DPYD 1679T>G genotype
1679T>G genotype
Excluded: DPYD 2846A>T genotype
2846A>T genotype
Disease stage
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Must have received: fluoropyrimidine-containing chemotherapy — advanced CRC
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)
Cannot have received: investigational drug
Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment
Cannot have received: radio- or chemotherapy
Exception: palliative radiation (1x 8Gy) is allowed; except radiotherapy focused on the liver
radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment
Cannot have received: major surgery
Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery
Lab requirements
Blood counts
ANC of ≥1.5 x 10^9/L; Platelet count of ≥100 x 10^9/L
Kidney function
serum creatinine ≤ 1.5 x ULN; creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD)
Liver function
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
Minimal acceptable safety laboratory values: ANC of ≥1.5 x 10^9/L; Platelet count of ≥100 x 10^9/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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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