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Experimental drug combo targets Hard-to-Treat pancreatic cancer

NCT ID NCT04158635

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether adding the drug bosentan to standard chemotherapy (gemcitabine and nab-paclitaxel) is safe and tolerable for people with pancreatic cancer that cannot be removed by surgery. The study involves 21 adults and aims to find the best dose of bosentan while monitoring side effects. Researchers hope this combination may slow or stop tumor growth better than chemotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bosentan (a drug that blocks the hormone endothelin) combined with chemotherapy drugs gemcitabine and nab-paclitaxel
What this could lead to
If it works, this could point toward a new combination treatment to help control advanced pancreatic cancer that cannot be surgically removed.
What could go wrong
This is a very early Phase 1 trial with only 21 participants, focused on safety and dosing. The study is currently suspended, and it is unknown if the combination will improve outcomes or cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria * Adult patients with unresectable pancreatic carcinoma * Patients must be a candidate to receive one of the following chemotherapy combinations as determined by the treating physician: Arm A2: gemcitabine plus nab-paclitaxel given every 2 weeks (arm A1 is closed per this amendment) Arm B: mFOLFIRINOX given every 2 weeks * Willingness to permit study team to obtain and use archival tissue, if already existing, or, be willing to undergo a fresh tumor biopsy if clinically possible (exceptions may be provided by study PI if medically unsafe to perform biopsy). * Weight ≥ 40 kg * ANC ≥ 1500/mm3; platelets ≥ 100,000/mm3 * AST, ALT ≤ 1.5 x ULN. Patients with liver metastases ≤ 3 x ULN * Total serum bilirubin ≤ 1.5 x ULN * Creatinine clearence ≥ 60 mL/min Main Exclusion Criteria * Current or planned use of Warfarin, Cyclosporine A, Rifampicin, Glyburide (other diabetic medications are allowed) * Current or planned use of agents contraindicated for use with strong CYP3A4 inducers * Strong inhibitors or inducers of CYP2C9 * Strong inhibitors or inducers of CYP3A * Agent or agents that moderately inhibit both CYP2C9 and CYP3A (via a single concomitant agent, or co-administration of concomitant agents) * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. * Current or history of ≥ Grade 2 peripheral neuropathy * Known allergy to eggs or any of the components within the study agents and/or their excipients.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

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