NCT02151084Active, not recruitingPhase 2
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer
A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 28 May 2014
- Start date
- Nov 2014
- Primary completion date
- May 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02151084
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 57
- From Nov 2014 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progressing within 3 or 6 months of receiving certain treatments
- Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor
- May not have received prior chemotherapy for non-resectable/metastatic disease.
- Prior MEK, RAS, or RAF inhibitors or history of hypersensitivity to study drugs.
- Incomplete recovery from previous surgery
- Undergoing treatment with curative intent
- Receiving potent inhibitors or inducers of CYP3A4/5, CYP2C19 and CYP1A2 can continue with caution
Other illness
- 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
- 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
Other
- Progressing within 6 months of adjuvant treatment.
- Ampullary carcinoma
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.