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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00075218
First received: January 6, 2004
Last updated: August 31, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: Placebo
Drug: SU011248
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Best Overall Tumor Response During Double-blind Treatment Phase [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Confirmed Objective Response (CR or PR) in Subjects [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to Tumor Response (TTR) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • Duration of Performance Status Maintenance [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in EQ-5D Health State Profile Index [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]

Enrollment: 361
Study Start Date: December 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B 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.
Active Comparator: A 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.

  Eligibility

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

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
  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: NCT00075218

  Show 61 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00075218     History of Changes
Obsolete Identifiers: NCT00085618
Other Study ID Numbers: A6181004
Study First Received: January 6, 2004
Results First Received: May 6, 2009
Last Updated: August 31, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014