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

NCT04329949 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-11-18

Study results available
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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.

Conditions

Interventions

DRUG

Relacorilant, 100 mg and 25 mg

Relacorilant is supplied as capsules for oral dosing.

DRUG

Nab-paclitaxel

Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • William Guyer, PharmD · Corcept Therapeutics, Menlo Park, CA 94025

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-08-23
Completion
2022-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329949 on ClinicalTrials.gov