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A Study to Evaluate lbrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors
||A Phase 1 b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors
||Wasif Saif, MD
||Jessika E Silva
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.
- Must have RCC (clear cell), urothelial carcinoma (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
- Must have hematologic, hepatic and renal function as defined by laboratory values
- Must have a negative serum or urine pregnancy test for females of childbearing potential
- Must not use of warfarin while on treatment
- Must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Must not have major surgery within 4 weeks of first dose of study drug
This study will be divided into two parts and cohorts will be separated based on indication (RCC, urothelial carcinoma, gast or gastro-esophaeal junctional adenocarcinoma or K-RAS/N-RAS. In the first phase, treatment will continue in 21-day cycles until toxicity or progression. During this time a CT/MRI will be performed at baseline and every 2 cycles. The first part will continue until the recommended phase 2 dose has been established for each cohort. In the second phase, recurrence of visits will depend on the cohort but subjects will require a CT/MRI at baseline and every 2 cycles. Blood samples for PK and PD will be collected through the study. Tumor biopsies at baseline and progression may also be required.