Park Ridge, Illinois 60068

  • Gastrointestinal Stromal Tumor

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.


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


Study is Available At:


Original ID:

A6181004


NCT ID:

NCT00075218


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

361


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:December 2003
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:August 2009
Last Changed Date:August 31, 2009
First Received Date:January 6, 2004
First Results Date:May 6, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Progression Free Survival (PFS)
Time Frame:Day 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Best Overall Tumor Response During Double-blind Treatment Phase
Time Frame:Day 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Confirmed Objective Response (CR or PR) in Subjects
Time Frame:Day 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Tumor Response (TTR)
Time Frame:Day 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Performance Status Maintenance
Time Frame:Day 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in EQ-5D Health State Profile Index
Time Frame:Day 1 & 28 of each cycle : duration of double-blind treatment phase
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Arm Name:B
Intervention Type:Drug
Name:SU011248
Description:50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Arm Name:A

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:B
Study Arm Type:Active Comparator
Arm Name:A

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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