Biliary Tract CarcinomaPhase 2NCT02151084
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer
A Phase 2 study testing Selumetinib, Cisplatin and Gemcitabine in people with Biliary Tract Carcinoma and Gallbladder Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- What is being tested?
- Selumetinib, Cisplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- No evidence of active uncontrolled infection
- Capable of giving written consent
- Acceptable recovery of previous side effects
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- Being tested
- Selumetinib, Cisplatin, Gemcitabine
- Keywords
- randomized, selumetinib, tablets, cisplatin, gemcitabine, non-resectable, recurrent, metstatic
- Medical subject headings
- Gallbladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelumetinibDrug
Also called AZD6244
CisplatinDrug
Also called Platinol
GemcitabineDrug
Also called Gemzar
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Continuous Dosing) | Experimental | Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1)
On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. Receives: Drug: Selumetinib; Drug: Cisplatin; Drug: Gemcitabine |
| Arm B (Sequential Dosing) | Experimental | Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout
On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle.
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. Receives: Drug: Selumetinib; Drug: Cisplatin; Drug: Gemcitabine |
| Arm C (Standard Care) | Experimental | Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. Receives: Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumor size in millimetres
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: 10 weeks post initiation of therapy
Secondary outcomes (6)
Number of participants with objective response and/or stable disease
Measured: 6 months post initiation of therapy
Percentage of patients without progressive disease
Measured: 10 weeks post initiation of therapy
Progression-free survival in months
Measured: Enrollment to disease progression or death
Overall survival in months
Measured: Time from enrollment to date of death
Total incidence of adverse events
Measured: 2 years
Total rate of grade 3 and 4 toxicities
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Knox, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151084
- Sponsor's protocol ID
- BIL-MEK
- Status last verified
- Jun 2026
- First submitted
- 28 May 2014
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02151084
- Acronym / sponsor ID
- BIL-MEK
- Conditions
- Biliary Tract Carcinoma, Gallbladder Carcinoma
- Keywords
- randomized, selumetinib, tablets, cisplatin, gemcitabine, non-resectable, recurrent, metstatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Continuous Dosing) | Experimental | Drug: Selumetinib, Drug: Cisplatin, Drug: GemcitabineRun-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1) On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. |
| Arm B (Sequential Dosing) | Experimental | Drug: Selumetinib, Drug: Cisplatin, Drug: GemcitabineRun-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. |
| Arm C (Standard Care) | Experimental | Drug: Cisplatin, Drug: GemcitabineCisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelumetinibAlso: AZD6244 | Drug | Arm A (Continuous Dosing), Arm B (Sequential Dosing) |
| CisplatinAlso: Platinol | Drug | Arm A (Continuous Dosing), Arm B (Sequential Dosing), Arm C (Standard Care) |
| GemcitabineAlso: Gemzar | Drug | Arm A (Continuous Dosing), Arm B (Sequential Dosing), Arm C (Standard Care) |
Primary outcome
Change in tumor size in millimetres
Time frame: 10 weeks post initiation of therapy
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
6 secondary outcomes
Number of participants with objective response and/or stable disease
Time frame: 6 months post initiation of therapy
Percentage of patients without progressive disease
Time frame: 10 weeks post initiation of therapy
Progression-free survival in months
Time frame: Enrollment to disease progression or death
Overall survival in months
Time frame: Time from enrollment to date of death
Total incidence of adverse events
Time frame: 2 years
Total rate of grade 3 and 4 toxicities
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Knox, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selumetinib, Cisplatin and Gemcitabine in people with Biliary Tract Carcinoma and Gallbladder Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumor size in millimetres (time frame: 10 weeks post initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.