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

Overview

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).

Detailed Description

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.

Who Can Participate

Inclusion Criteria

Signed and dated informed consent form prior to screening procedures

Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)

Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study

Life expectancy of ≥3 months

Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Able to provide informed consent and comply with protocol requirements

Able to swallow and retain oral medication and does not have uncontrolled emesis

Has adequate gastrointestinal absorption

Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.

If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred >12 months after completing the last dose, and no persistent treatment-related toxicities can be present.

Adequate organ function

Negative pregnancy test for patients of childbearing potential

Agree to use protocol defined precautions to avoid pregnancy

Exclusion Criteria

Any major surgery within 4 weeks prior to enrollment

Prior treatment as follows:

1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug

Received gemcitabine or nab-paclitaxel to treat their PDAC

Known germline or somatic breast cancer gene (BRCA) mutation

Peripheral neuropathy from any cause >Grade 1

Medical conditions requiring chronic or frequent treatment with corticosteroids

History of severe hypersensitivity or severe reaction to any of study drugs or their excipients

Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.

Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation

Active infection with HIV, hepatitis C or hepatitis B virus

Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases

History of other malignancy within 3 years prior to enrollment

Taking protocol-prohibited medications

Concurrent treatment with other investigational treatment studies for cancer

Has received a live vaccine within 30 days prior to the study start date

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.