Clinical trial NCT00372567: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, Week 5, and every 8 weeks until Year 2
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to 2 years
measure: Time to Pain Relief Response (TTPR)
timeFrame: Day 28 of Cycle 1 up to 26
measure: Time to Treatment Failure (TTF)
timeFrame: Day 28 of Cycle 1 up to 26
measure: Number of Participants With Objective Response of Complete Response or Partial Response
timeFrame: Day 28 of Cycle 1 up to 26
measure: Time to Tumor Response (TTR)
timeFrame: Day 28 of Cycle 1 up to 26
measure: Duration of Response (DR)
timeFrame: Day 28 of Cycle 1 up to 26
measure: Time to Pain Progression (TTPP)
timeFrame: Day 28 of Cycle 1 up to 26
measure: Number of Participants With Pain Relief Response
timeFrame: Day 28 of Cycle 1 up to 26
measure: Number of Participants With Pain Progression
timeFrame: Day 28 of Cycle 1 up to 26
measure: Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
timeFrame: Days 1 and 28 of each cycle
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
timeFrame: Days 1 and 28 of each cycle
measure: Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
timeFrame: Days 1 and 28 of each cycle
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
timeFrame: Days 1 and 28 of each cycle
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Farmington Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Lai Chi Kok
country: Hong Kong
facility: Pfizer Investigational Site
state: Kowloon
city: Tuen Mun
country: Hong Kong
facility: Pfizer Investigational Site
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: San Giovanni Rotondo
country: Italy
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: