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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [Baseline and up to 32 weeks]. Count Of Participants, Participants. Complete response: Relacorilant With Nab-paclitaxel (n=43): 0. Partial response: Relacorilant With Nab-paclitaxel (n=43): 0. No response: Relacorilant With Nab-paclitaxel (n=43): 43.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) Per Investigator Assessment [Baseline and up to 48 weeks]. Count Of Participants, Participants. Complete response: Relacorilant With Nab-paclitaxel (n=43): 0. Partial response: Relacorilant With Nab-paclitaxel (n=43): 0. No response: Relacorilant With Nab-paclitaxel (n=43): 43.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Best Overall Response (BOR) [Baseline and up to 32 weeks]. Count Of Participants, Participants. Complete response: Relacorilant With Nab-paclitaxel (n=31): 0. Partial response: Relacorilant With Nab-paclitaxel (n=31): 0. Stable disease: Relacorilant With Nab-paclitaxel (n=31): 20. Progressive disease: Relacorilant With Nab-paclitaxel (n=31): 10. Non-evaluable: Relacorilant With Nab-paclitaxel (n=31): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DOR) [Time of response up to 32 weeks].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) [Enrollment through 18 weeks]. Count Of Participants, Participants. Relacorilant With Nab-paclitaxel (n=31): 5.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) [Baseline and up to 31 weeks.]. Median, Months (95% Confidence Interval). Relacorilant With Nab-paclitaxel (n=43): 2.4 (1.4 to 4.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Baseline and up to 70 weeks]. Median, Months (95% Confidence Interval). Relacorilant With Nab-paclitaxel (n=43): 3.9 (2.8 to 4.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) [Enrollment through 3 months, 6 months, and 12 months]. Number, Percentage of participants (95% Confidence Interval). 3 months: Relacorilant With Nab-paclitaxel (n=43): 44.77 (28.97 to 59.38). 6 months: Relacorilant With Nab-paclitaxel (n=43): 8.00 (1.57 to 21.50). 12 months: Relacorilant With Nab-paclitaxel (n=43): NA (NA to NA) [The Kaplan-Meier estimates and corresponding 95% confidence interval (CI) for the Progression-Free Survival (PFS) Rates at Months 3, 6, and 12 are provided. Due to no subjects being progression-free by Month 12, the PFS rate and 95% CI at that timepoint are not estimable and shown as NA.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Enrollment through 3 months, 6 months, and 12 months]. Number, Percentage of participants (95% Confidence Interval). 3 months: Relacorilant With Nab-paclitaxel (n=43): 64.12 (47.65 to 76.61). 6 months: Relacorilant With Nab-paclitaxel (n=43): 21.55 (10.23 to 35.58). 12 months: Relacorilant With Nab-paclitaxel (n=43): 10.77 (3.44 to 22.91).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Cancer Antigen (CA)19-9 [Enrollment through 8 weeks and 16 weeks]. Count Of Participants, Participants. 8 weeks: Relacorilant With Nab-paclitaxel (n=39): 5. 16 weeks: Relacorilant With Nab-paclitaxel (n=39): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria [Enrollment through 6 weeks]. Count Of Participants, Participants. Complete metabolic response: Relacorilant With Nab-paclitaxel (n=23): 0. Partial metabolic response: Relacorilant With Nab-paclitaxel (n=23): 6. Stable metabolic disease: Relacorilant With Nab-paclitaxel (n=23): 9. Progressive metabolic disease: Relacorilant With Nab-paclitaxel (n=23): 8.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Progression (TTP) [Baseline and up to 32 weeks]. Median, Months (95% Confidence Interval). Relacorilant With Nab-paclitaxel (n=43): 4.2 (1.6 to NA) [The upper 95% confidence interval of median TTP was not calculable due to insufficient number of patients with events.].