Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Corcept Therapeutics
- Study ID
- NCT07259317
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Adenocarcinoma
- Carcinoma, Pancreatic Ductal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Relacorilant 150 mg once daily (QD) — DRUGRelacorilant will be administered as capsules for oral dosing on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions.
- Nab-paclitaxel 100 mg/m^2 — DRUGNab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
- Gemcitabine 1000 mg/m^2 — DRUGGemcitabine will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
Study Details
This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).
Key Dates
- Start date
- Jan 27, 2026
- Status verified
- Apr 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Relacorilant in Combination with Nab-paclitaxel and GemcitabineThe patient will receive relacorilant 150 mg, administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1, day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions. Nab-paclitaxel (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) will be administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.
Primary Outcome Measure
Progression-Free Survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
Central Contacts
- Corcept Therapeutics650-684-0171
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site 02 | Scottsdale | Arizona | 85258 | - |
| Site 04 | Los Angeles | California | 90025 | - |
| Site 06 | Atlanta | Georgia | 30322 | - |
| Site 03 | Grand Rapids | Michigan | 49503 | - |
| Site 10 | East Brunswick | New Jersey | 08816 | - |
| Site 08 | Albany | New York | 12206 | - |
| Site 05 | Lake Success | New York | 11042 | - |
| Site 07 | Shirley | New York | 11967 | - |
| Site 09 | Nashville | Tennessee | 37203 | - |
| Site 01 | San Antonio | Texas | 78229 | - |
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