Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

Active:	Yes
Cancer Type:	Pancreatic Cancer Unknown Primary	NCT ID:	NCT07259317
Trial Phases:	Phase II	Protocol IDs:	CORT125134-558 (primary)
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Corcept Therapeutics Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT07259317

Summary

This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing,
pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel
and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma
(PDAC).

Objectives

This study will include 2 parts. In Part 1 (dose finding), approximately 6 patients will
be enrolled to individual dose-finding cohorts. Cohorts will receive various dose
concentrations of relacorilant, nab-paclitaxel, and gemcitabine at various dosing
schedules. In all dose-finding cohorts, relacorilant will be administered orally under
fed conditions, once daily for 3 days on the day before (excluding Cycle 1 Day -1), the
day of, and the day after nab-paclitaxel and gemcitabine. Enrollment will be paused after
each cohort has been filled until the safety review committee (SRC) provides
recommendations. If maximum tolerated dose (MTD) criteria are not met in a cohort, then
either a dose-finding cohort at a more intense dose and/or schedule may be enrolled, or a
dose and schedule at/below the MTD may be selected as the optimal dose and schedule, and
Part 2 may be initiated. If MTD criteria are met, then a dose-finding cohort at a less
intense dose and/or schedule may be enrolled, or dose-finding may end without proceeding
to Part 2.

In Part 2 (expansion), each patient will receive the optimal dose and schedule of
relacorilant, nab-paclitaxel, and gemcitabine as identified in Part 1. Analysis of Part 2
will include data for patients from Part 1 who were enrolled in the optimal dose and
schedule used in Part 2.

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