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New treatment option for Adenocarcinoma
Official title Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT07259317
What this study is testing
What is Relacorilant?
Relacorilant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adenocarcinoma.
Also referred to as CORT125134.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Any major surgery within 4 weeks prior to enrollment
- 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...
- Received gemcitabine or nab-paclitaxel to treat their PDAC
- Known germline or somatic breast cancer gene (BRCA) mutation
See the full eligibility 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
- Any major surgery within 4 weeks prior to enrollment
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- Atlanta, Georgia, United States
- Goshen, Indiana, United States
- Westwood, Kansas, United States
- Grand Rapids, Michigan, United States
- East Brunswick, New Jersey, United States
- Morristown, New Jersey, United States
- Albany, New York, United States
- Lake Success, New York, United States
- Shirley, New York, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; Atlanta, Georgia, United States; Goshen, Indiana, United States; Westwood, Kansas, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.