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

NCT00075218 | Completed Phase 3 Results DMC

• 1 other identifier: A6181004
• Study Type: interventional
• Target: 361
• Locations: 11 countries
• Sites: 61

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (2)

• Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase

  Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).

  Day 28 of each 6-week cycle : duration of double-blind treatment phase

• Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study

  Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).

  Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)

Secondary Outcomes (12)

• Progression Free Survival (PFS)

  Day 28 of each cycle : duration of double-blind treatment phase

• Overall Survival Status of Subjects

  clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

• Overall Survival

  clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

• Overall Survival Based on the Rank Preserving Structural Failure Time Method

  clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

• Best Overall Tumor Response During Double-blind Treatment Phase

  Day 28 of each cycle : duration of double-blind treatment phase

Study Arms (2)

B

PLACEBO COMPARATOR

Drug: Placebo

A

ACTIVE COMPARATOR

Drug: SU011248

Interventions

Placebo DRUG

50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

B

SU011248 DRUG

50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

A

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Sponsors & Collaborators

• Pfizer: lead

Study Sites (61)

Pfizer Investigational Site

Duarte, California, 91010, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095-6984, United States

Location

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Los Angeles, California, 90095, United States

Location

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Pasadena, California, 91105, United States

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Santa Monica, California, 90404, United States

Location

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Stanford, California, 94305, United States

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Washington D.C., District of Columbia, 20010, United States

Location

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Miami, Florida, 33136, United States

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Tampa, Florida, 33612, United States

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Park Ridge, Illinois, 60068, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Detroit, Michigan, 48201, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63110, United States

Location

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New York, New York, 10021-6007, United States

Location

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New York, New York, 10022, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

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Cleveland, Ohio, 44195-0002, United States

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Columbus, Ohio, 43210, United States

Location

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Columubs, Ohio, 43210, United States

Location

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Portland, Oregon, 97201, United States

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Philadelphia, Pennsylvania, 19111, United States

Location

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Nashville, Tennessee, 37232, United States

Location

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Seattle, Washington, 98109, United States

Location

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Seattle, Washington, 98195, United States

Location

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Madison, Wisconsin, 53792-0001, United States

Location

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Garran, Australian Capital Territory, 2605, Australia

Location

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Camperdown, New South Wales, 2050, Australia

Location

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Randwick, New South Wales, 2031, Australia

Location

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Auchenflower, Queensland, 4066, Australia

Location

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Ashford, South Australia, 5035, Australia

Location

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Bedford Park, South Australia, 5042, Australia

Location

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East Melbourne, Victoria, 3002, Australia

Location

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Leuven, 3000, Belgium

Location

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Toronto, Ontario, M5G 1X5, Canada

Location

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Montreal, Quebec, H2L 4M1, Canada

Location

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Lyon, 69373, France

Location

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Marseille, 13385, France

Location

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Villejuif, 94805, France

Location

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Aviano, PN, 33081, Italy

Location

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Candiolo, Torino, 10060, Italy

Location

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Bologna, 40138, Italy

Location

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Genova, 16132, Italy

Location

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Milan, 20133, Italy

Location

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Milan, 20141, Italy

Location

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Milan, 20162, Italy

Location

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Torino, 10153, Italy

Location

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Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

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Rotterdam, South Holland, 3075 EA, Netherlands

Location

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Singapore, 119074, Singapore

Location

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Singapore, 169610, Singapore

Location

Pfizer Investigational Site

Singapore, 308433, Singapore

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

Location

Pfizer Investigational Site

L'Hospitalet Del Llobregat, Barcelona, 08907, Spain

Location

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Madrid, Madrid, 28041, Spain

Location

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Lausanne, CH-1011, Switzerland

Location

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Sutton, Surrey, SM2 5NG, United Kingdom

Location

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Leeds, LS9 7TF, United Kingdom

Location

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London, W1T 3AA, United Kingdom

Location

Pfizer Investigational Site

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Related Publications (1)

• Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.

  PMID: 17046465 DERIVED

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib

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

Limitations and Caveats

Duration of Tumor Response could not be reliably estimated at the time of analysis.

Results Point of Contact

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

ClinicalTrials.govCallCenter@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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2004
• First Posted: January 8, 2004
• Study Start: December 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 28, 2009
• Results First Posted: September 28, 2009

Record last verified: 2009-08

Locations

ES (3); CA (2); NL (2); AU (7); GB (4); US (27); CH (1); BE (1); FR (3); SG (3); IT (8)