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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

September 5, 2006
March 15, 2011
June 2007
November 2009   (final data collection date for primary outcome measure)
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.
To evaluate the duration of progression free survival (PFS) on sunitanib or imitanib. PFS is defined as the time from date of first treatment dose to progression of the gastrointestinal stromal tumor or death for any reason, whichever comes first.
Complete list of historical versions of study NCT00372567 on ClinicalTrials.gov Archive Site
  • 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.
  • Objective response (OR)
  • Time-to tumor response (TTR)
  • Duration of response (DR)
  • Time-to-treatment failure (TTF)
  • Overall survival time
  • Pain relief/ Pain progression
  • Patient-reported outcomesSafety and tolerability of sunitinib administered in a continuous treatment regimen compared to imatinib
Not Provided
Not Provided
 
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
  • Drug: sunitinib malate
    37.5 mg daily
    Other Name: Sutent
  • Drug: imatinib mesylate
    800mg daily
  • Experimental: A
    Intervention: Drug: sunitinib malate
  • Active Comparator: B
    Intervention: Drug: imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
69
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Spain,   United Kingdom
 
NCT00372567
A6181112
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

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