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

January 23, 2024 updated by: University Health Network, Toronto

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Gemcitabine
Other Names:
  • Gemzar
Drug: Cisplatin
Other Names:
  • Platinol
Drug: Selumetinib
Other Names:
  • AZD6244
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: Gemcitabine
Other Names:
  • Gemzar
Drug: Cisplatin
Other Names:
  • Platinol
Drug: Selumetinib
Other Names:
  • AZD6244
Experimental: Arm C (Standard Care)
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Cisplatin
Other Names:
  • Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tumor size in millimetres
Time Frame: 10 weeks post initiation of therapy
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
10 weeks post initiation of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with objective response and/or stable disease
Time Frame: 6 months post initiation of therapy
6 months post initiation of therapy
Percentage of patients without progressive disease
Time Frame: 10 weeks post initiation of therapy
10 weeks post initiation of therapy
Progression-free survival in months
Time Frame: Enrollment to disease progression or death
Enrollment to disease progression or death
Overall survival in months
Time Frame: Time from enrollment to date of death
Time from enrollment to date of death
Total incidence of adverse events
Time Frame: 2 years
2 years
Total rate of grade 3 and 4 toxicities
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimated)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIL-MEK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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