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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02151084
Collaborator
(none)
57
Enrollment
1
Location
3
Arms
99
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Selumetinib
Other Names:
  • AZD6244

    • Drug: Cisplatin
    Other Names:
  • Platinol

    • Drug: Gemcitabine
    Other Names:
  • Gemzar

    		•
    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.

    Drug: Selumetinib
    Other Names:
  • AZD6244

    • Drug: Cisplatin
    Other Names:
  • Platinol

    • Drug: Gemcitabine
    Other Names:
  • Gemzar

    		•
    Experimental: Arm C (Standard Care)

    Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

    Drug: Cisplatin
    Other Names:
  • Platinol

    • Drug: Gemcitabine
    Other Names:
  • Gemzar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in tumor size in millimetres [10 weeks post initiation of therapy]

      Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Secondary Outcome Measures

    1. Number of participants with objective response and/or stable disease [6 months post initiation of therapy]

    2. Percentage of patients without progressive disease [10 weeks post initiation of therapy]

    3. Progression-free survival in months [Enrollment to disease progression or death]

    4. Overall survival in months [Time from enrollment to date of death]

    5. Total incidence of adverse events [2 years]

    6. Total rate of grade 3 and 4 toxicities [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Jennifer Knox, M.D., Princess Margaret Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT02151084
    Other Study ID Numbers:
    • BIL-MEK
    First Posted:
    May 30, 2014
    Last Update Posted:
    Apr 15, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by University Health Network, Toronto
    randomized
    selumetinib
    tablets
    cisplatin
    gemcitabine
    non-resectable
    recurrent
    metstatic
    Additional relevant MeSH terms:
    Carcinoma
    Gemcitabine

    Study Results

    No Results Posted as of Apr 15, 2021