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

This study is currently recruiting participants.
Verified June 2016 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02151084
First Posted: May 30, 2014
Last Update Posted: June 22, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose

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 Intervention Phase
Biliary Tract Carcinoma Gallbladder Carcinoma Drug: Selumetinib Drug: Cisplatin Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in tumor size in millimetres [ Time Frame: 10 weeks post initiation of therapy ]
    Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: November 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: AZD6244
Drug: Cisplatin
Other Name: Platinol
Drug: Gemcitabine
Other Name: 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 Name: AZD6244
Drug: Cisplatin
Other Name: Platinol
Drug: Gemcitabine
Other Name: Gemzar
Experimental: Arm C (Standard Care)
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Drug: Cisplatin
Other Name: Platinol
Drug: Gemcitabine
Other Name: Gemzar

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151084


Contacts
Contact: Jennifer Knox, M.D. 416-946-2399

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Jennifer Knox, M.D.    416-946-2399      
Principal Investigator: Jennifer Knox, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Jennifer Knox, M.D. Princess Margaret Cancer Centre
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02151084     History of Changes
Other Study ID Numbers: BIL-MEK
First Submitted: May 28, 2014
First Posted: May 30, 2014
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by University Health Network, Toronto:
randomized
selumetinib
tablets
cisplatin
gemcitabine
non-resectable
recurrent
metstatic

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs