Active — Not RecruitingPhase 2

A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer

Canada57 participantsStarted 2014-11

Plain-language summary

This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer. Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in tumor size in millimetres

Timeframe: 10 weeks post initiation of therapy

Trial details

NCT IDNCT02151084

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Biliary Tract Carcinoma trials