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

Gastrointestinal Stromal Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00372567
• Other study ID #: A6181112
• Status: Terminated
• Phase: Phase 3
• First received: September 5, 2006
• Last updated: March 15, 2011
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• sunitinib malate
37.5 mg daily
• imatinib mesylate
800mg daily

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Hamburg
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Lai Chi Kok	Kowloon
Hong Kong	Pfizer Investigational Site	Tuen Mun	New Territories
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	San Giovanni Rotondo
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Valencia
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Peters	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Hong Kong,  Italy,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 5, and every 8 weeks until Year 2	No
Secondary	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.	Baseline up to 2 years	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	Time to Treatment Failure (TTF)	TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Day 28 of Cycle 1 up to 26	No
Secondary	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.	Days 1 and 28 of each cycle	No
Secondary	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.	Days 1 and 28 of each cycle	No
Secondary	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.	Days 1 and 28 of each cycle	No
Secondary	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.	Days 1 and 28 of each cycle	No

External Links

•   To obtain contact information for a study center near you, click here.