Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Status and phase
Conditions
Treatments
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
Sex
Ages
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
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Any major surgery within 4 weeks prior to enrollment
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Prior treatment as follows:
- Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
- Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug
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Received gemcitabine or nab-paclitaxel to treat their PDAC
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Known germline or somatic breast cancer gene (BRCA) mutation
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Peripheral neuropathy from any cause >Grade 1
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Medical conditions requiring chronic or frequent treatment with corticosteroids
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History of severe hypersensitivity or severe reaction to any of study drugs or their excipients
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Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
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Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
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Active infection with HIV, hepatitis C or hepatitis B virus
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Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases
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History of other malignancy within 3 years prior to enrollment
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Taking protocol-prohibited medications
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Concurrent treatment with other investigational treatment studies for cancer
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Has received a live vaccine within 30 days prior to the study start date
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Corcept Therapeutics
Data sourced from clinicaltrials.gov
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