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

Corcept Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Pancreatic Ductal; Adenocarcinoma

Treatments: Drug: Gemcitabine 1000 mg/m^2; Drug: Relacorilant 150 mg once daily (QD); Drug: Nab-paclitaxel 100 mg/m^2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07259317

CORT125134-558

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

Experimental group

Description:

The 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 and gemcitabine infusions. Nab-paclitaxel (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) will be administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.

Treatment:

Drug: Nab-paclitaxel 100 mg/m^2

Drug: Relacorilant 150 mg once daily (QD)

Drug: Gemcitabine 1000 mg/m^2