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

Phase 2RecruitingNCT07259317

Corcept Therapeutics60 enrolled

Overview

This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenocarcinoma Carcinoma, Pancreatic Ductal

Interventions

Relacorilant 150 mg once daily (QD)DRUG

Relacorilant will be administered as capsules for oral dosing on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions.

Nab-paclitaxel 100 mg/m^2DRUG

Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Gemcitabine 1000 mg/m^2DRUG

Gemcitabine will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 ≤6 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 therapy to treat metastatic disease * 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

Locations (1)

Site 01

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first.

Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Secondary Outcomes

Overall Survival (OS)

Time frame: From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months

Best Overall Response (BOR)

Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Objective Response Rate (ORR)

To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1.

Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Duration of Response (DoR)

To evaluate DOR as the time from the first CR or PR to first documented PD or death, whichever comes first.

Time frame: From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Clinical Benefit Rate (CBR)

To evaluate clinical benefit rate as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.

Central Contacts

Corcept Therapeutics

CONTACT

650-684-0171 corceptstudy558@corcept.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.