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

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Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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
  • For RCC:
  • previously received at least 1 but no more than 4 lines of therapy, one therapy must have included a VEGF TKI
  • ECOG performance status of 0-1 (score of 2 may be acceptable)
  • For urothelial carcinoma:
  • previously received at least 1 but no more than 2 lines of therapy, one therapy must have included a platinum based regimen
  • ECOG performance status of 0-1
  • For gastric or GEJ adenocarcinoma:
  • previously received at least 1 but no more than 3 lines of therapy, one therapy must have included a fluoropyrimidine based regimen
  • ECOG performance status of 0-1
  • For CRC:
  • previously received at least 2 but no more than 4 lines of therapy, which must have included both an irinotecan and an oxaliplatin based regimen
  • ECOG performance status of 0-1 (score of 2 may be acceptable)
  • For all cohorts:
  • Adequate hematologic function:
  • Absolute neutrophil count (ANC) >1500 cells/mm3
  • For RCC, platelet count ≥80,000 cells/mm3
  • For urothelial carcinoma, gastric or GEJ adenocarcinoma, and CRC, platelet count ≥100,000 cells/mm3
  • For RCC, urothelial carcinoma, and gastric or GEJ adenocarcinoma, hemoglobin ≥8.0 g/dL
  • For CRC, hemoglobin ≥9.0 g/dL
  • Adequate hepatic and renal function defined as:
  • AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  • Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  • Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
  • Estimated Creatinine Clearance ≥30 mL/min

Exclusion Criteria

  • For RCC, prior treatment with everolimus or temsirolimus
  • For urothelial carcinoma, prior treatment with any taxane
  • For gastric or GEJ adenocarcinoma, prior treatment with any taxane
  • For CRC, prior treatment with cetuximab or panitumumab
  • For all cohorts:
  • concomitant use of warfarin or other Vitamin K antagonists
  • history of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • major surgery within 4 weeks of first dose of study drug
  • requires treatment with strong CYP3A inhibitors
  • known bleeding disorders or hemophilia

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lee S. Rosen
Phone: 310-633-8411
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Cheryl Kefauver
Phone: 323-865-0845 Email: Cheryl.Kefauver@med.usc.edu
San Diego
University of California San Diego
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Pharmacyclics LLC.

Trial IDs

Primary ID PCYC-1128-CA
Secondary IDs NCI-2016-00449
Clinicaltrials.gov ID NCT02599324