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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma, Advanced Urothelial Carcinoma, Advanced Gastric Adenocarcinoma, Metastatic Colorectal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02599324

Run by

Pharmacyclics LLC.

People needed

263

Starts

2015-12-01

Expected to finish

2021-08-20

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 cohort 1 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 cohort 3 gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must have included a fluoropyrimidine regimen For cohort 4 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 may not qualify 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.

Where it is running

• Banner MD Anderson Cancer Center /ID# 1128-0802 — Gilbert, Arizona, United States
• University of Arizona Cancer Center - Tucson /ID# 1128-1546 — Tucson, Arizona, United States
• Alta Bates Comprehensive Cancer Center /ID# 1128-0135 — Berkeley, California, United States
• St Marys Medical Center /ID# 1128-0969 — Daly City, California, United States
• Duplicate_University of California San Diego/ Moores Cancer Center /ID# 1128-0241 — La Jolla, California, United States
• VA Long Beach Healthcare System /ID# 1128-0480 — Long Beach, California, United States
• USC Norris Cancer Center /ID# 1128-0209 — Los Angeles, California, United States
• UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1128-0008 — Orange, California, United States
• Salinas Valley Memorial Hosp /ID# 1128-0482 — Salinas, California, United States
• Premiere Oncology, A Medical Corporation /ID# 1128-1085 — Santa Monica, California, United States
• St. Joseph Health /ID# 1128-1462 — Santa Rosa, California, United States
• Gregory Smith, MD (Private Practice) /ID# 1128-0419 — St. Helena, California, United States
• Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411 — Norwalk, Connecticut, United States
• Georgetown University Hospital /ID# 1128-0824 — Washington D.C., District of Columbia, United States
• Duplicate_Cancer Specialist of North Florida (CSNF) ( R ) /ID# 1128-1093 — Jacksonville, Florida, United States
• IACT Health-Columbus /ID# 1128-1389 — Columbus, Georgia, United States
• Northshore Kellogg Cancer Center /ID# 1128-0484 — Evanston, Illinois, United States
• Franciscan Health Indianapolis /ID# 1128-1125 — Indianapolis, Indiana, United States
• Horizon Oncology Research Center /ID# 1128-0337 — Lafayette, Indiana, United States
• University of Iowa Hospitals and Clinics /ID# 1128-0766 — Iowa City, Iowa, United States
• The University of Kansas Cancer Center /ID# 1128-0706 — Fairway, Kansas, United States
• East Jefferson General Hospital /ID# 1128-1084 — Metairie, Louisiana, United States
• Duplicate_Tufts Medical Center /ID# 1128-0016 — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer In /ID# 1128-0130 — Detroit, Michigan, United States
• Clearview Cancer Institute /ID# 1128-0965 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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