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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151084
Recruitment Status : Active, not recruiting
First Posted : May 30, 2014
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE November 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
Change in tumor size in millimetres [ Time Frame: 10 weeks post initiation of therapy ]
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Tract Carcinoma
  • Gallbladder Carcinoma
Intervention  ICMJE
  • Drug: Selumetinib
    Other Name: AZD6244
  • Drug: Cisplatin
    Other Name: Platinol
  • Drug: Gemcitabine
    Other Name: Gemzar
Study Arms  ICMJE
  • Experimental: Arm A (Continuous Dosing)

    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.

    Interventions:
    • Drug: Selumetinib
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Experimental: Arm B (Sequential Dosing)

    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.

    Interventions:
    • Drug: Selumetinib
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Experimental: Arm C (Standard Care)
    Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2014)
15
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151084
Other Study ID Numbers  ICMJE BIL-MEK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Knox, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP