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) — DRUG
    Relacorilant 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 — DRUG
    Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Gemcitabine 1000 mg/m^2 — DRUG
    Gemcitabine 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 Gemcitabine
    The 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

Locations (10)

FacilityCityStateZIPSite coordinators
Site 02ScottsdaleArizona85258-
Site 04Los AngelesCalifornia90025-
Site 06AtlantaGeorgia30322-
Site 03Grand RapidsMichigan49503-
Site 10East BrunswickNew Jersey08816-
Site 08AlbanyNew York12206-
Site 05Lake SuccessNew York11042-
Site 07ShirleyNew York11967-
Site 09NashvilleTennessee37203-
Site 01San AntonioTexas78229-

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