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

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).

Eligibility

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

Conditions3

Interventions6

Locations15 sites

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