EUCTR2015-003656-40-GB
Active, not recruiting
Phase 1
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors - PCYC-1128-CA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pharmacyclics LLC
- Enrollment
- 308
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed:
- •\- RCC (clear cell)
- •\- Urothelial carcinoma (transitional cell)
- •\- Gastric or GEJ adenocarcinoma
- •\- K\-RAS or N\-RAS wild\-type EGFR expressing CRC
- •2\. One or more measurable lesions per RECIST 1\.1 criteria.
- •3\. The following prior criteria should be followed:
- •\- Metastatic RCC: minimum of 1 and maximum of 4 prior regimens, one or more of which must have included a VEGF\-TKI
- •Advanced (locally recurrant and or metastatic) UC: minimum of 1 andmaximum of 2 prior regimens, one of which must have included a platinum based regimen (cohort 2\) or a checkpoint inhibitor (cohort 5\)
- •\-Advanced (locally recurrent and/or metastatic) urothelial carcinoma: minimum of 1 and maximum of 2 prior regimens, one of which must be a platinum based regimen
Exclusion Criteria
- •Disease\-Related
- •1\. Anticancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days of the first dose of study drug (4 weeks for nitrosureas, mitomycin C, or antibody based therapies)
- •2\. Prior treatment with: ?
- •\- Everolimus or temsirolimus (RCC cohort)
- •\- Any taxane (urothelial carcinoma cohort 2\)
- •\- Any taxane (gastric adenocarcinoma cohort) ?
- •\- Cetuximab or panitumumab (CRC cohort)
- •3\. Prior radiotherapy to measurable lesion, unless documented
- •progression has occurred post\-irradiation
- •4\. Lack of recovery from previous therapeutic radiation (persistence of Grade \=2 radiation\-related toxicity) or planned radiation therapy during the study period
Outcomes
Primary Outcomes
Not specified
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