Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00372567
First received: September 5, 2006
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: sunitinib malate
Drug: imatinib mesylate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline, Week 5, and every 8 weeks until Year 2 ] [ Designated as safety issue: No ]
    Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
    Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.

  • Time to Pain Relief Response (TTPR) [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

  • Time to Treatment Failure (TTF) [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.

  • Number of Participants With Objective Response of Complete Response or Partial Response [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  • Time to Tumor Response (TTR) [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  • Duration of Response (DR) [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]

    Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.

    Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.


  • Time to Pain Progression (TTPP) [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

  • Number of Participants With Pain Relief Response [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

  • Number of Participants With Pain Progression [ Time Frame: Day 28 of Cycle 1 up to 26 ] [ Designated as safety issue: No ]
    Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

  • Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm [ Time Frame: Days 1 and 28 of each cycle ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.

  • Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm [ Time Frame: Days 1 and 28 of each cycle ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.

  • Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm [ Time Frame: Days 1 and 28 of each cycle ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.

  • Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm [ Time Frame: Days 1 and 28 of each cycle ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.


Enrollment: 69
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: sunitinib malate
37.5 mg daily
Other Name: Sutent
Active Comparator: B Drug: imatinib mesylate
800mg daily

Detailed Description:

The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion Criteria:

  • Current treatment with any chemotherapy other than imatinib.
  • Current treatment with any dose of imatinib other than 400 mg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372567

Locations
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Pfizer Investigational Site
Creve Coeur, Missouri, United States, 63141
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Peters, Missouri, United States, 63376
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Germany
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Hamburg, Germany, 22767
Hong Kong
Pfizer Investigational Site
Lai Chi Kok, Kowloon, Hong Kong, 0
Pfizer Investigational Site
Tuen Mun, New Territories, Hong Kong, 0
Pfizer Investigational Site
Hong Kong, Hong Kong, 0
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
San Giovanni Rotondo, Italy, 71013
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Valencia, Spain, 46009
United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YH
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Pfizer Investigational Site
London, United Kingdom, SW3 6JJ
Pfizer Investigational Site
London, United Kingdom, NW1 2PG
Pfizer Investigational Site
London, United Kingdom, W1
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00372567     History of Changes
Other Study ID Numbers: A6181112
Study First Received: September 5, 2006
Results First Received: October 27, 2010
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014