TerminatedPhase 3

Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Stopped: The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.

United States43 participantsStarted 2020-06-30

Plain-language summary

This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. An investigational product, cytotoxic chemotherapy, or targeted agent within 14 days
✕. Radiotherapy within 21 days
✕. Palliative radiotherapy within 1 week of Cycle 1 Day 1, or if toxicities from radiotherapy are Grade 2 severity or higher or have not recovered to baseline
✕. Systemic or prescription-strength topical corticosteroids for the purposes of treating a chronic nononcologic indication within 21 days.
✕. Bilirubin ≥1.5 × ULN (Upper Limit of Normal)
✕. Amylase \>2 × ULN and abdominal pain or amylase \>3 × ULN (with or without symptoms)
✕. Fever or signs of infection
✕. Decreasing hemoglobin or signs of blood loss.

What they're measuring

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

Timeframe: Baseline and up to 32 weeks

Trial details

NCT IDNCT04329949

SponsorCorcept Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-23

Results submitted2023-09-07

View on ClinicalTrials.gov More Metastatic Pancreatic Ductal Adenocarcinoma trials