Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
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|ClinicalTrials.gov Identifier: NCT04329949|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2020
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Ductal Adenocarcinoma||Drug: Relacorilant, 100 mg and 25 mg Drug: Nab paclitaxel||Phase 3|
Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of metastatic pancreatic ductal adenocarcinoma.
Eligible patients are those with metastatic pancreatic adenocarcinoma (mPDAC) who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma (PDAC) in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.
Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)|
|Actual Study Start Date :||June 30, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
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.
Drug: Relacorilant, 100 mg and 25 mg
Relacorilant is supplied as capsules for oral dosing.
Other Name: CORT125134
Drug: Nab paclitaxel
Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Other Name: Abraxane
- Objective Response Rate (ORR) per Blinded Independent Central Review (BICR) [ Time Frame: Enrollment through 24 months ]Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RESIST) v1.1, according to a Blinded Independent Central Review (BICR).
- Objective Response Rate (ORR) per Investigator Assessment [ Time Frame: Enrollment through 24 months ]Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RESIST) v1.1, according to Investigator assessment.
- Best Overall Response (BoR) [ Time Frame: Enrollment through 24 months ]To evaluate the best overall response per RESIST v1.1.
- Duration of Response (DoR) [ Time Frame: Time of response up to 24 months ]To evaluate the duration of response according to the Investigator and Blinded Independent Central Review.
- Disease Control Rate (DCR) [ Time Frame: 18 weeks from enrollment ]To evaluate patients disease control rate or complete response, partial response or stable disease at 18 weeks, as assessed by the Investigator.
- Progression-Free Survival (PFS) [ Time Frame: Enrollment through 24 months ]To evaluate progression-free survival, as assessed by the Investigator
- Overall Survival (OS) [ Time Frame: Enrollment through 24 months ]To evaluate overall survival.
- Progression-Free Survival (PFS) [ Time Frame: 3 months, 6 months, and 12 months after Enrollment ]To evaluate progression-free survival at 3, 6 and 12 months
- Overall Survival (OS) [ Time Frame: 3 months, 6 months, and 12 months after Enrollment ]To evaluate overall survival at 3, 6, and 12, months.
- Cancer Antigen (CA)19-9 [ Time Frame: 8 and 16 weeks from Baseline ]To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks, in patients who have elevated CA19-9 at baseline.
- Tumor Response per EORTC criteria [ Time Frame: 6 weeks post initiation of treatment ]To assess tumor response based on changes in FDG-PET scan at 6 weeks per the European Organization for Research and Treatment of Cancer (EORTC) criteria, according to the Blinded Independent Central Review (BICR)
- Time to Progression (TTP) [ Time Frame: From date of first treatment of relicorilant plus nab-paclitaxel until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]To evaluate the time to progression by comparing duration of disease control on prior nab-paclitaxel therapy (if applicable) and on the most recent therapy (study treatment of relacorilant and Nab-paclitaxel).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329949
|Study Director:||Andreas Grauer, MD||Corcept Therapeutics, Menlo Park, CA 94025|