Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00075218
Previous Study | Return to List | Next Study

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00075218
Recruitment Status : Completed
First Posted : January 8, 2004
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 6, 2004
First Posted Date  ICMJE January 8, 2004
Results First Submitted Date  ICMJE May 6, 2009
Results First Posted Date  ICMJE September 28, 2009
Last Update Posted Date September 28, 2009
Study Start Date  ICMJE December 2003
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
  • Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase ]
    Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
  • Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ]
    Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
  • Progression Free Survival (PFS) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]
    Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).
  • Overall Survival Status of Subjects [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]
    Number of subjects alive at end of study.
  • Overall Survival [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]
    Time from date of randomization to date of death due to any cause.
  • Overall Survival Based on the Rank Preserving Structural Failure Time Method [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]
    time from date of randomization to date of death due to any cause (rank preserving structural failure time method).
  • Best Overall Tumor Response During Double-blind Treatment Phase [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]
    Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • Confirmed Objective Response (CR or PR) in Subjects [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]
    Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
  • Time to Tumor Response (TTR) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]
    Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.
  • Duration of Performance Status Maintenance [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]
    Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.
  • Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]
    25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)
  • Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]
    MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.
  • Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]
    Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
  • Change From Baseline in EQ-5D Health State Profile Index [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]
    Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Brief Summary A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumor
Intervention  ICMJE
  • Drug: Placebo
    50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
  • Drug: SU011248
    50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Study Arms  ICMJE
  • Placebo Comparator: B
    Intervention: Drug: Placebo
  • Active Comparator: A
    Intervention: Drug: SU011248
Publications * Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2009)
361
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
  • Failed Gleevec treatment or intolerant to Gleevec therapy

Key Exclusion Criteria:

  • Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Italy,   Netherlands,   Singapore,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00075218
Other Study ID Numbers  ICMJE A6181004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2009

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