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

NCT00372567 | Terminated Phase 3 Results DMC

• 1 other identifier: A6181112
• Study Type: interventional
• Target: 69
• Locations: 7 countries
• Sites: 25

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.

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Overall Survival (OS)

  Baseline up to 2 years

• Time to Pain Relief Response (TTPR)

  Day 28 of Cycle 1 up to 26

• Time to Treatment Failure (TTF)

  Day 28 of Cycle 1 up to 26

• Number of Participants With Objective Response of Complete Response or Partial Response

  Day 28 of Cycle 1 up to 26

• Time to Tumor Response (TTR)

  Day 28 of Cycle 1 up to 26

Study Arms (2)

A

EXPERIMENTAL

Drug: sunitinib malate

B

ACTIVE COMPARATOR

Drug: imatinib mesylate

Interventions

sunitinib malate DRUG

37.5 mg daily

Also known as: Sutent

A

imatinib mesylate DRUG

800mg daily

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

You may not qualify if:

• Current treatment with any chemotherapy other than imatinib.
• Current treatment with any dose of imatinib other than 400 mg

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Göttingen, 37075, Germany

Location

Pfizer Investigational Site

Hamburg, 22767, Germany

Location

Pfizer Investigational Site

Lai Chi Kok, Kowloon, 0, Hong Kong

Location

Pfizer Investigational Site

Tuenmen, New Territories, 0, Hong Kong

Location

Pfizer Investigational Site

Hong Kong, 0, Hong Kong

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

San Giovanni Rotondo, 71013, Italy

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46009, Spain

Location

Pfizer Investigational Site

Glasgow, G12 0YH, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

London, NW1 2PG, United Kingdom

Location

Pfizer Investigational Site

London, SW3 6JJ, United Kingdom

Location

Pfizer Investigational Site

London, W1, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Pyrimidines

Limitations and Caveats

On 18 June 2009, the study was prematurely stopped for operational reasons (poor recruitment, lack of interest, and change of clinical practice) and not related to safety concerns

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 17, 2011
• Results First Posted: December 31, 2010

Record last verified: 2011-03

Locations

US (6); KR (3); DE (2); GB (6); ES (2); IT (3); HK (3)