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Endothelin Receptor Antagonist

Combination Chemotherapy for Pancreatic Cancer

Phase 1
Recruiting
Led By Ravi Salgia
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable disease
Histologic diagnosis of pancreatic carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial studies the side effects and best dose of bosentan when given with gemcitabine and nab-paclitaxel for the treatment of unresectable pancreatic cancer.

Who is the study for?
This trial is for adults with pancreatic cancer that can't be surgically removed. They must not have had prior chemotherapy, except certain types in the adjuvant setting if recurrence occurred after 6 months. Participants need functioning major organs, no severe allergies to study drugs or their components, and agree to use effective birth control methods.Check my eligibility
What is being tested?
The trial tests bosentan combined with gemcitabine and nab-paclitaxel chemotherapy to see if it's more effective for treating unresectable pancreatic cancer than chemotherapy alone. It also aims to determine the best dose of bosentan and assess its side effects when used with these chemotherapies.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Bosentan may cause liver issues or headaches. The combination could increase the chance of experiencing these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition cannot be treated with surgery.
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I have been diagnosed with pancreatic cancer.
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My kidney function, measured by creatinine clearance, is good.
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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance
Dose limiting toxicities (DLTs)
Incidence of adverse events
Secondary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Time to treatment failure (TTF)
Other outcome measures
Analysis of loci that encode organic anion transporting polypeptides (OATP) in participants who experience severe hepatotoxicity, increased during protocol therapy
Histopathology/ structural assessment and quantification of the miRNA profile
Levels of nab-paclitaxel, bosentan and active plasma metabolite Ro 48-5033
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 13-21Experimental Treatment5 Interventions
Patients receive bosentan PO BID on days 1-21 of cycle 1 and days 1-21 of subsequent cycles. Patients also receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 10-12Experimental Treatment5 Interventions
Patients receive bosentan PO BID on days -7 to 21 and days 1-21 of subsequent cycles. Patients also receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 1-9Experimental Treatment5 Interventions
Patients receive bosentan PO BID on days 8-21 of cycle 1 and days 1-21 of subsequent cycles. Patients also receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosentan
2010
Completed Phase 4
~1530
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,112 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,439 Total Patients Enrolled
Ravi SalgiaPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Bosentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04158635 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 13-21, Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 1-9, Treatment (bosentan, nab-paclitaxel, gemcitabine) - Participant 10-12
Pancreatic Cancer Clinical Trial 2023: Bosentan Highlights & Side Effects. Trial Name: NCT04158635 — Phase 1
Bosentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04158635 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this experiment still underway?

"That is accurate. The clinicaltrials.gov website has information indicating that this trial is still looking for patients. This research study was originally posted on September 1st, 2021 and the most recent update was on November 9th, 2021. Right now, the plan is to enroll 21 individuals at a single site."

Answered by AI

How many human test subjects are involved in this experiment?

"The listings on clinicaltrials.gov show that this study is still recruiting patients. The posting went up on September 1st, 2021 and was updated November 9th, 2021. They are seeking 21 individuals from a single location to take part in the trial."

Answered by AI

For what reason is Bosentan most commonly prescribed?

"Bosentan is a medication used to treat non-small cell lung cancer that has spread locally. Additionally, it can be used to manage metastatic bladder cancer, urinary bladder conditions, and mediastinitis."

Answered by AI

What are the negative effects associated with Bosentan?

"Since this is a Phase 1 trial, there is limited data supporting safety and efficacy, so our team at Power estimates the safety of Bosentan to be a 1."

Answered by AI

Could you please share what other research studies have included Bosentan?

"Out of 1199 total studies investigating Bosentan, 337 are still running clinical trials. Of these Phase 3 trials, the majority are based in Shanghai with 60149 locations overall running trials for this drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
2021. "Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04158635.
~8 spots leftby Jan 2026
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