Disease: Renal Cell Carcinoma (RCC); Urothelial Carcinoma; Gastric Adenocarcinoma; Colorectal Adenocarcinoma (CRC)
Protocol: PCYC-1128-CA

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

Study Schema (N = up to 261)

  • A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors.
  • Currently enrolling subjects with Renal Cell Carcinoma (RCC), Urothelial Carcinoma, Gastric Adenocarcinoma, and Colorectal Adenocarcinoma (CRC).

pcyc-1128-ca-phases

Primary Objective

  • To evaluate the safety and tolerability of ibrutinib in combination with everolimus, paclitaxel, docetaxel, or cetuximab
  • To evaluate the efficacy of ibrutinib in combination with everolimus, paclitaxel, docetaxel, or cetuximab by assessing Progression Free Surivival (PFS) of RCC and urothelial carcinoma and Overall Response Rate (ORR) in gastric adenocarcinoma and CRC

Key Eligibility Criteria

(Not a complete list of inclusion and exclusion criteria)

Minimum Age: 18 Years

Inclusion Criteria:

  • RCC (clear cell), urothelial carcinoma (transitional cell), gastric or gastroesophageal 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 adenocarcima, 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

 

 

For more information on this trial, click below

The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit www.clinicaltrials.gov. For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.