A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

Update Il y a 4 ans
Reference: EUCTR2015-003656-40

Woman and Man

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Extract

Phase 1b: Primary Objective: - To determine the recommended Phase 2 dose (RP2D) of ibrutinib in combination with everolimus in RCC, paclitaxel in urothelial carcinoma, docetaxel in gastric adenocarcinoma and cetuximab in CRC. Phase 2: Primary Objectives: - To assess progression-free survival (PFS) of ibrutinib combination therapy in RCC and urothelial carcinoma, and to assess the ORR of ibrutinib combination therapy in gastric adenocarcinoma and CRC


Inclusion criteria

  • Metastatic renal cell carcinoma (RCC), advanced urothelial carcinoma, advanced gastric (including gastro-esophageal [GEJ]) adenocarcinoma, and metastatic colorectal adenocarcinoma (CRC)

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