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New drug cocktail shows promise in Hard-to-Treat biliary cancers

NCT ID NCT02151084

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

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
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tests whether adding the targeted drug selumetinib to standard chemotherapy (cisplatin and gemcitabine) works better than chemotherapy alone for advanced biliary tract or gallbladder cancer. The study enrolls 57 adults who have not had prior treatment. Researchers are measuring tumor shrinkage, survival, and side effects.

What this could mean

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

Active substance
Selumetinib (a targeted cancer drug) combined with cisplatin and gemcitabine (standard chemotherapy)
What this could lead to
If successful, this could lead to a new treatment option that slows tumor growth and improves survival for people with advanced biliary cancer.
What could go wrong
This is a small, early-phase trial (Phase II) with only 57 participants, so results may not apply to everyone. Adding selumetinib may also increase side effects like fatigue or liver issues.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Started

Nov 2014

Expected to finish

Sep 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.

Inclusion Criteria: * Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer * No prior systemic therapy * Performance status 0, 1, or 2 * Age 18 years or older * Estimated life expectancy \> 3 months * Adequate hematological, liver, renal function * No evidence of active uncontrolled infection * Capable of giving written consent * Acceptable recovery of previous side effects Exclusion Criteria: * Progressing within 3 or 6 months of receiving certain treatments * Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor * Progressing within 6 months of adjuvant treatment. * May not have received prior chemotherapy for non-resectable/metastatic disease. * Prior MEK, RAS, or RAF inhibitors or history of hypersensitivity to study drugs. * Ampullary carcinoma * Incomplete recovery from previous surgery * Undergoing treatment with curative intent * Prior malignancy that could interfere with the response evaluation * Severe or uncontrolled systemic diseases or lab finding that makes it undesirable for patient to participate * Any psychiatric or other disorder likely to impact consent * Pregnant or breastfeeding * Patients with significant cardiac-related issues * History of eye-related issues. * Systemic disease, active infection, bleeding diatheses or renal transplant, including hep B, hep C or HIV * Receiving potent inhibitors or inducers of CYP3A4/5, CYP2C19 and CYP1A2 can continue with caution

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Conditions

The condition(s) this trial relates to.

bile duct carcinoma biliary tract cancer gallbladder cancer gallbladder carcinoma gallbladder neoplasm Recurrence

As listed by the trial registrant

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

Biliary tract carcinoma Gallbladder carcinoma

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

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