Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

Phase 1/2 Completed 263 enrolled Pharmacyclics LLC.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors.

Timeline

Start: 2015-12-01
Primary completion: 2021-08-20
Completion: 2021-08-20

Publications

Oh DY, Maqueda MA, Quinn DI, O'Dwyer PJ, Chau I, Kim SY, Duran I, Castellano D, Berlin J, Mellado B, Williamson SK, Lee KW, Marti F, Mathew P, Saif MW, Wang D, Chong E, Hilger-Rolfe J, Dean JP, Arkenau HT. Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study. BMC Cancer. 2023 Nov 3;23(1):1056. doi: 10.1186/s12885-023-11539-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	60 mg/m2	Other
Subject	Docetaxel	Small molecule	75 mg/m2	Other
Subject	Everolimus	Small molecule	10 mg	Oral
Subject	Ibrutinib	Small molecule	560 mg	Oral
Subject	Ibrutinib	Small molecule	840 mg	Oral
Subject	Paclitaxel	Small molecule	80 mg/m2	Other
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

Summary

Timeline

Publications

Drugs

Indications