Summary

for people ages 18 years and up (full criteria)
at UCLAUCSD
study started
estimated completion

Description

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 advanced gastrointestinal and genitourinary tumors.

Official Title

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

Keywords

Metastatic Renal Cell Carcinoma Advanced Urothelial Carcinoma Advanced Gastric Adenocarcinoma Metastatic Colorectal Adenocarcinoma Carcinoma Adenocarcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Paclitaxel Docetaxel Albumin-Bound Paclitaxel Pembrolizumab Everolimus Sirolimus Cetuximab Ibrutinib Renal Cell Carcinoma - Enrollment Closed Urothelial Carcinoma - Enrollment Closed Gastric Adenocarcinoma - Enrollment Closed Colorectal Adenocarcinoma - Enrollment Closed

Eligibility

You can join if…

Open to people ages 18 years and up

  • RCC (clear cell), urothelial carcinoma (UC) (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
  • For RCC: minimum of 1 and maximum of 4 prior regimens, one or more of which must have included a VEGF-TKI
  • For UC cohort 2: minimum of 1 and maximum of 2 prior regimens, one of which must have included a platinum-based regimen
  • For UC cohort 5: Minimum of 1 and maximum of 2 prior regimens, one of which must have included a checkpoint inhibitor.
  • For UC cohort 6:
  • Locally advanced or mUC who are not eligible for cisplatin chemo with a PDL-1 score (CPS) of ≥ 10 without prior treatment.
  • Locally advanced or mUC who have progressed on platinum chemo or within 12 months of neo- or adjuvant therapy with a platinum chemotherapy. A minimum of 1 and maximum of 2 prior therapies.
  • For gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must have included a fluoropyrimidine regimen
  • For CRC: minimum of 2 and maximum of 4 prior regimens, which must have included both an irinotecan and an oxaliplatin based regimen unless unable to tolerate irinotecan chemotherapy

Laboratory:

  • Adequate hematologic function:
  • Absolute neutrophil count ≥1500 cells/mm3 (1.5 x 109/L)
  • Platelet count >80,000 cells/mm3 (80 x 109/L) for cohort 1 (RCC)
  • Platelet counts >100,000 cells/mm3 (100 x 109/L) for all UC cohorts
  • Hemoglobin ≥8.0 g/dL. for cohort 1 (RCC),all UC cohorts, and cohort 3 (GC)
  • Hemoglobin ≥9.0 g/dL for cohort 4 (CRC)
  • Adequate hepatic and renal function defined as:
  • Serum aspartate transaminase (AST) and/or alanine transaminase (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) with the exception of subjects in the GC cohort where
  • docetaxel is administered, these subjects must have bilirubin within normal limits (WNL)
  • Estimated Creatinine Clearance ≥30 mL/min (Cockcroft-Gault)

You CAN'T join if...

  • Prior treatment with:
  • Everolimus or temsirolimus (RCC cohort 1)
  • Any taxane ( UC cohort of ibrutinib + paclitaxel) (cohort 2)
  • Checkpoint inhibitors (UC cohort 6)
  • Any taxane (GC cohort 3)
  • Cetuximab or panitumumab (CRC cohort 4)
  • 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
  • UC cohort 6 only:
  • Subjects who have an active, known or suspected autoimmune disease.
  • Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
  • Non-steroid immunosuppressive medications within 14 days before the first dose of ibrutinib and pembrolizumab.
  • Subjects in whom prior anti PD-1 / anti-PD-L1 therapy was intolerable and required discontinuation of treatment.

Locations

  • UC San Diego Moores Cancer Center completed
    La Jolla California 92093 United States
  • UCLA accepting new patients
    Santa Monica California 90404 United States
  • St. Mary's Medical Center accepting new patients
    San Francisco California 94117 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