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

NCT02599324 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2023-11-18

Study results available
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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

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.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • Pharmacyclics LLC · Pharmacyclics LLC.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2021-08-20
Completion
2021-08-20
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599324 on ClinicalTrials.gov