Actively Recruiting
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Led by Corcept Therapeutics · Updated on 2026-04-23
60
Participants Needed
10
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form prior to screening procedures
- Histologic or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)
- Initial metastatic disease diagnosis occurred within 6 weeks before enrollment
- Life expectancy of at least 3 months
- Radiographic confirmation of metastatic disease with at least one measurable distant tumor per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to provide informed consent and follow protocol requirements
- Able to swallow and retain oral medication without uncontrolled vomiting
- Adequate gastrointestinal absorption
- No prior systemic anticancer therapy for metastatic disease
- If prior PDAC chemotherapy was given, disease progression occurred more than 12 months after last dose and no ongoing treatment toxicities
- Adequate organ function
- Negative pregnancy test if of childbearing potential
- Agree to use precautions to avoid pregnancy
You will not qualify if you...
- Major surgery within 4 weeks before enrollment
- Prior treatment for metastatic disease including radiotherapy, surgery, chemotherapy, immunotherapy, or investigational therapy
- Use of systemic, inhaled, or prescription corticosteroids within 5 times their half-life before first study drug dose
- Prior treatment with gemcitabine or nab-paclitaxel for PDAC
- Known germline or somatic BRCA mutation
- Peripheral neuropathy greater than Grade 1
- Medical conditions requiring chronic or frequent corticosteroid treatment
- History of severe hypersensitivity or severe reactions to study drugs or their components
- Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
- Uncontrolled conditions that may affect safety or study results
- Active HIV, hepatitis B, or hepatitis C infection
- Untreated or uncontrolled brain metastases
- History of other cancers within 3 years before enrollment
- Use of protocol-prohibited medications
- Concurrent participation in other investigational cancer treatment studies
- Receipt of live vaccine within 30 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Site 02
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Site 04
Los Angeles, California, United States, 90025
Actively Recruiting
3
Site 06
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Site 03
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Site 10
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
6
Site 08
Albany, New York, United States, 12206
Actively Recruiting
7
Site 05
Lake Success, New York, United States, 11042
Actively Recruiting
8
Site 07
Shirley, New York, United States, 11967
Actively Recruiting
9
Site 09
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Site 01
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Corcept Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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