Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
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-nave patients with metastatic pancreatic adenocarcinoma (PDAC).
Pancreatic
Phase II
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Gemcitabine,
Nab-Paclitaxel,
Relacorilant
Cardin, Dana
National
Vanderbilt University
09-22-2026
Eligibility
18 Years and older
ALL
false
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
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
