Actively Recruiting
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Led by City of Hope Medical Center · Updated on 2026-04-17
21
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the side effects and best dose of bosentan and how well it works when given together with gemcitabine and nab-paclitaxel for the treatment of pancreatic cancer that cannot be removed by surgery (unresectable). Bosentan may block the hormone endothelin and prevent the growth and spread of pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bosentan with chemotherapy (gemcitabine and nab-paclitaxel) may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
CONDITIONS
Official Title
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with unresectable pancreatic carcinoma
- Candidates for gemcitabine plus nab-paclitaxel chemotherapy every 2 weeks
- Willing to allow archival tissue use or undergo fresh tumor biopsy if possible
- Weight at least 40 kg
- Absolute neutrophil count (ANC) at least 1500/mm3
- Platelet count at least 100,000/mm3
- AST and ALT levels no more than 1.5 times the upper limit of normal (ULN); if liver metastases, up to 3 times ULN
- Total serum bilirubin no more than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
You will not qualify if you...
- Current or planned use of Warfarin, Cyclosporine A, Rifampicin, or Glyburide (other diabetic meds allowed)
- Use of drugs contraindicated with strong CYP3A4 inducers
- Use of strong inhibitors or inducers of CYP2C9 or CYP3A
- Use of moderate inhibitors of both CYP2C9 and CYP3A
- History of other cancers except treated skin cancer, in situ cervical cancer, or cancers in remission for 5 years
- Current or history of grade 2 or higher peripheral neuropathy
- Known allergy to eggs or any components of study drugs or excipients
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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