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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT04329949
Phase
PHASE3
Status
Terminated

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Relacorilant, 100 mg and 25 mg — DRUG
    Relacorilant is supplied as capsules for oral dosing.
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Study Details

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.

Key Dates

First listed
Apr 1, 2020
Start date
Jun 30, 2020
Status verified
Oct 2023
Primary completion
Aug 23, 2021
Completion
Mar 25, 2022

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relacorilant with nab-paclitaxel
    Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Primary Outcome Measure

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [ Time Frame: Baseline and up to 32 weeks ]

Locations (18)

FacilityCityStateZIPSite coordinators
Site #038ScottsdaleArizona85258-
Site #171DuarteCalifornia91010-
Site #076Los AngelesCalifornia90095-
Site #032AuroraColorado80045-
Site #009AtlantaGeorgia30322-
Site #184GoshenIndiana46526-
Site #065BaltimoreMaryland21231-
Site #058DetroitMichigan48201-
Site #185OmahaNebraska68114-
Site #182BuffaloNew York14263-
Site #044New YorkNew York10016-
Site #222New YorkNew York10016-
Site #077ColumbusOhio43210-
Site #186ToledoOhio43614-
Site #172PittsburghPennsylvania15232-
Site #175KnoxvilleTennessee37920-
Site #176NashvilleTennessee37232-
Site #173SeattleWashington98195-

Find similar trials in Scottsdale, AZ

By research site
Site #038· Scottsdale, AZSite #171· Duarte, CASite #076· Los Angeles, CASite #032· Aurora, COSite #009· Atlanta, GASite #184· Goshen, IN

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