ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors
Part of paid clinical trials in Grand Rapids, Michigan.
- Sponsor
- Constellation Pharmaceuticals
- Study ID
- NCT03525795
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CPI-1205 — DRUGAdministered orally
- ipilimumab — DRUGAdministered intravenously
Study Details
This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab. This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.
Key Dates
- Start date
- Dec 14, 2017
- Status verified
- May 2022
- Primary completion
- Jun 12, 2019
- Completion
- Jun 12, 2019
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CPI-1205 Combination with ipilimumab
Primary Outcome Measure
Phase 1: Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: 1 year ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | 49546 | - |
| The University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| South Texas Oncology & Hematology | San Antonio | Texas | 78229 | - |
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