Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Renal Cell Carcinoma (RCC) Urothelial Carcinoma Gastric Adenocarcinoma Colorectal Adenocarcinoma (CRC) Carcinoma Adenocarcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Paclitaxel Docetaxel Albumin-Bound Paclitaxel Everolimus Sirolimus Cetuximab ibrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • UCLA accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02599324
Phase
Phase 1/2
Study Type
Interventional
Last Updated
August 7, 2018