NCT02599324

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Renal Cell Carcinoma
• Advanced Urothelial Carcinoma
• Advanced Gastric Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ibrutinib	Ibrutinib administered orally once daily with 8 ounces (approximately 240 mL) of water.
DRUG	everolimus	Everolimus 10 mg tablets should be taken orally once daily at the same time every day, either consistently with food or consistently without food. Four (4) x 2.5 mg tablets or two (2) x 5.0 mg tablets may be substituted if 10 mg tablet strength is not available.
DRUG	paclitaxel	Paclitaxel should be administered as a 60-minute (±10 minutes) infusion. Paclitaxel should be given at a dose level of 80 mg/m\^2, once weekly, in continual 3 weekly cycles.
DRUG	docetaxel	Docetaxel administered as a 60 minute infusion (±10 minutes) at a dose level of 60 - 75 mg/m\^2 (according to local institutional standard of care), given continually in 21-day cycles.
DRUG	cetuximab	Cetuximab 400 mg/m\^2 administered as a 120-minute IV infusion. The recommended subsequent weekly dose (all other infusions) is 250 mg/m\^2 infused over 60 minutes.
DRUG	pembrolizumab	Pembrolizumab 200 mg intravenous (IV) every 3 weeks.

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2015-11-06
• Last updated: 2023-11-18
• Results posted: 2022-10-26

Locations

65 sites across 4 countries: United States, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study