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

Primary Purpose

Gastrointestinal Stromal Tumor

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sunitinib malate
imatinib mesylate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
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 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)
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)
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
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 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 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)
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
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
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
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
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
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
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.

Full Information

First Posted
September 5, 2006
Last Updated
March 15, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00372567
Brief Title
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
Sutent
Intervention Description
37.5 mg daily
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
800mg daily
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Baseline, Week 5, and every 8 weeks until Year 2
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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 Frame
Baseline up to 2 years
Title
Time to Pain Relief Response (TTPR)
Description
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 Frame
Day 28 of Cycle 1 up to 26
Title
Time to Treatment Failure (TTF)
Description
TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.
Time Frame
Day 28 of Cycle 1 up to 26
Title
Number of Participants With Objective Response of Complete Response or Partial Response
Description
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 Frame
Day 28 of Cycle 1 up to 26
Title
Time to Tumor Response (TTR)
Description
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.
Time Frame
Day 28 of Cycle 1 up to 26
Title
Duration of Response (DR)
Description
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 Frame
Day 28 of Cycle 1 up to 26
Title
Time to Pain Progression (TTPP)
Description
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.
Time Frame
Day 28 of Cycle 1 up to 26
Title
Number of Participants With Pain Relief Response
Description
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.
Time Frame
Day 28 of Cycle 1 up to 26
Title
Number of Participants With Pain Progression
Description
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.
Time Frame
Day 28 of Cycle 1 up to 26
Title
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
Description
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.
Time Frame
Days 1 and 28 of each cycle
Title
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
Description
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.
Time Frame
Days 1 and 28 of each cycle
Title
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
Description
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.
Time Frame
Days 1 and 28 of each cycle
Title
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
Description
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.
Time Frame
Days 1 and 28 of each cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Pfizer Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pfizer Investigational Site
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Pfizer Investigational Site
City
Lai Chi Kok
State/Province
Kowloon
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Tuen Mun
State/Province
New Territories
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Pfizer Investigational Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 0YH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W1
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181112&StudyName=Safety%20And%20Effectiveness%20Of%20Daily%20Dosing%20With%20Sunitinib%20Or%20Imatinib%20In%20Patients%20With%20Gastrointestinal%20Stromal%20Tumors%20
Description
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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

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