Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02151084

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Biliary Tract Carcinoma Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gallbladder Carcinoma Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selumetinib

Drug

Other names: AZD6244

Cisplatin

Drug

Other names: Platinol

Gemcitabine

Drug

Other names: Gemzar

Primary outcomes

  1. Change in tumor size in millimetres

    Time frame: 10 weeks post initiation of therapy

    Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary outcomes

  1. Number of participants with objective response and/or stable disease

    Time frame: 6 months post initiation of therapy

  2. Percentage of patients without progressive disease

    Time frame: 10 weeks post initiation of therapy

  3. Progression-free survival in months

    Time frame: Enrollment to disease progression or death

  4. Overall survival in months

    Time frame: Time from enrollment to date of death

  5. Total incidence of adverse events

    Time frame: 2 years

  6. Total rate of grade 3 and 4 toxicities

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
May 30, 2014
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.