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
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Conditions

  • Adenocarcinoma
  • Carcinoma, Pancreatic Ductal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relacorilant — DRUG
    Relacorilant will be administered as capsules for oral dosing.
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel will be administered via IV infusion.
  • Gemcitabine — DRUG
    Gemcitabine will be administered via IV infusion.

Study Details

This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).

Key Dates

Start date
Jan 27, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Relacorilant in Combination with Nab-paclitaxel and Gemcitabine
    The patient will receive relacorilant 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 intravenous (IV) infusions. Various dose levels and dosing schedules of relacorilant, nab-paclitaxel, and gemcitabine will be evaluated. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.

Primary Outcome Measure

Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1) [ Time Frame: Up to 28 days after the first dose of study treatment ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Site 02ScottsdaleArizona85258-
Site 04Los AngelesCalifornia90025-
Site 12OrangeCalifornia92868-
Site 06AtlantaGeorgia30322-
Site 14GoshenIndiana46526-
Site 03Grand RapidsMichigan49503-
Site 10East BrunswickNew Jersey08816-
Site 11MorristownNew Jersey07960-
Site 08AlbanyNew York12206-
Site 05Lake SuccessNew York11042-
Site 07ShirleyNew York11967-
Site 13CincinnatiOhio45219-
Site 09NashvilleTennessee37203-
Site 01San AntonioTexas78229-

Find similar trials in Scottsdale, AZ

By research site
Site 02· Scottsdale, AZSite 04· Los Angeles, CASite 12· Orange, CASite 06· Atlanta, GASite 14· Goshen, INSite 03· Grand Rapids, MI

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