Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- Drug: Relacorilant, 100 mg and 25 mg
- Registration Number
- NCT04329949
- Lead Sponsor
- Corcept Therapeutics
- Brief 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.
- Detailed Description
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 mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Relacorilant with nab-paclitaxel Relacorilant, 100 mg and 25 mg 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. Relacorilant with nab-paclitaxel 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 Measures
Name Time Method Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) Baseline and up to 32 weeks 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 (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Per Investigator Assessment Baseline and up to 48 weeks Percentage of patients with measurable disease at baseline who achieved confirmed CR or PR per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions.
Best Overall Response (BOR) Baseline and up to 32 weeks To evaluate the best overall response of CR, PR, stable disease (SD), or PD per RECIST v1.1. as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Duration of Response (DOR) Time of response up to 32 weeks To evaluate the duration of response as the time of objective response (CR or PR) to the time of disease progression or death, per RECIST v1.1 as assessed by BICR and the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Disease Control Rate (DCR) Enrollment through 18 weeks To evaluate patients disease control rate of CR, PR, or SD at 18 weeks, per RECIST v1.1 as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Progression-Free Survival (PFS) Enrollment through 3 months, 6 months, and 12 months To evaluate PFS as the percentage of patients who are progression-free at 3, 6, and 12 months per RECIST v1.1, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Overall Survival (OS) Enrollment through 3 months, 6 months, and 12 months To evaluate OS as the percentage of patients surviving at 3, 6, and 12, months.
Cancer Antigen (CA)19-9 Enrollment through 8 weeks and 16 weeks To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks in patients who have elevated CA19-9 at baseline. Response was defined as ≥50% reduction in CA19-9.
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria Enrollment through 6 weeks To assess tumor response based on changes in fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at 6 weeks per the EORTC criteria, as assessed by BICR.
Time to Progression (TTP) Baseline and up to 32 weeks To evaluate TTP as median time to disease progression per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Trial Locations
- Locations (18)
Site #186
🇺🇸Toledo, Ohio, United States
Site #009
🇺🇸Atlanta, Georgia, United States
Site #058
🇺🇸Detroit, Michigan, United States
Site #185
🇺🇸Omaha, Nebraska, United States
Site #175
🇺🇸Knoxville, Tennessee, United States
Site #038
🇺🇸Scottsdale, Arizona, United States
Site #032
🇺🇸Aurora, Colorado, United States
Site #172
🇺🇸Pittsburgh, Pennsylvania, United States
Site #222
🇺🇸New York, New York, United States
Site #176
🇺🇸Nashville, Tennessee, United States
Site #065
🇺🇸Baltimore, Maryland, United States
Site #076
🇺🇸Los Angeles, California, United States
Site #182
🇺🇸Buffalo, New York, United States
Site #184
🇺🇸Goshen, Indiana, United States
Site #171
🇺🇸Duarte, California, United States
Site #077
🇺🇸Columbus, Ohio, United States
Site #044
🇺🇸New York, New York, United States
Site #173
🇺🇸Seattle, Washington, United States