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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase II, Phase ITreatmentActive18 and overPCYC-1128-CA
NCI-2016-00449, NCT02599324

Trial 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.

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Pharmacyclics LLC.

    Trial Sites

    U.S.A.

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Lee S. Rosen
    Ph: 310-633-8411

    Lee S. Rosen
    Principal Investigator

    Kansas
    Kansas City

    University of Kansas Cancer Center

    Stephen K. Williamson
    Principal Investigator

    Oregon
    Portland

    OHSU Knight Cancer Institute

    Matthew Hiram Taylor
    Ph: 503-418-9324

    Matthew Hiram Taylor
    Principal Investigator

    Tennessee
    Nashville

    Vanderbilt University/Ingram Cancer Center

    Jordan D. Berlin
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT02599324

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.