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NCT00075218 Clinical Trial

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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00075218
Other study ID # A6181004
Secondary ID
Status Completed
Phase Phase 3
First received January 6, 2004
Last updated August 31, 2009
Start date December 2003
Est. completion date May 2008

Study information
Verified date August 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00085618

Recruitment information / eligibility
Status Completed
Enrollment 361
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Key Inclusion Criteria:

- 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

Key Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
• SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

Locations
Country Name City State
Australia Pfizer Investigational Site Ashford South Australia
Australia Pfizer Investigational Site Auchenflower Queensland
Australia Pfizer Investigational Site Bedford Park South Australia
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site East Melbourne Victoria
Australia Pfizer Investigational Site Garran Australian Capital Territory
Australia Pfizer Investigational Site Randwick New South Wales
Belgium Pfizer Investigational Site Leuven
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Toronto Ontario
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site VILLEJUIF Cedex
Italy Pfizer Investigational Site Aviano PN
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Candiolo Torino
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Torino
Netherlands Pfizer Investigational Site Groningen Gr
Netherlands Pfizer Investigational Site Rotterdam ZH
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'Hospitalet del Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
Switzerland Pfizer Investigational Site Lausanne
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Newcastle-Upon-Tyne
United Kingdom Pfizer Investigational Site Sutton Surrey
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columubs Ohio
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Duarte California
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Park Ridge Illinois
United States Pfizer Investigational Site Pasadena California
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Santa Monica California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Netherlands,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase Day 28 of each 6-week cycle : duration of double-blind treatment phase No
Primary Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) No
Secondary Progression Free Survival (PFS) Day 28 of each cycle : duration of double-blind treatment phase No
Secondary 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 No
Secondary Overall Survival clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug No
Secondary 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 No
Secondary Best Overall Tumor Response During Double-blind Treatment Phase Day 28 of each cycle : duration of double-blind treatment phase No
Secondary Confirmed Objective Response (CR or PR) in Subjects Day 28 of each cycle : duration of double-blind treatment phase No
Secondary Time to Tumor Response (TTR) Day 28 of each cycle : duration of double-blind treatment phase No
Secondary Duration of Performance Status Maintenance Day 28 of each cycle : duration of double-blind treatment phase No
Secondary Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) Day 1 & 28 of each cycle : duration of double-blind treatment phase No
Secondary Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) Day 1 & 28 of each cycle : duration of double-blind treatment phase No
Secondary Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Day 1 & 28 of each cycle : duration of double-blind treatment phase No
Secondary Change From Baseline in EQ-5D Health State Profile Index Day 1 & 28 of each cycle : duration of double-blind treatment phase No
See also
  Status Clinical Trial Phase
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Completed NCT01774162 - EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration N/A
Completed NCT01110668 - Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Phase 2
Terminated NCT00091078 - Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery Phase 2
Completed NCT00025246 - Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery Phase 2
Active, not recruiting NCT00265798 - Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate Phase 2
Recruiting NCT04143048 - A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
Recruiting NCT02931981 - Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor N/A
Not yet recruiting NCT02576080 - Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index Phase 3
Recruiting NCT01389583 - A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients Phase 2
Recruiting NCT00777504 - Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors Phase 4
Completed NCT00769782 - Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor Phase 2
Completed NCT00764595 - Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor Phase 2
Completed NCT00098579 - Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery Phase 1
Completed NCT00005862 - SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas Phase 2
Completed NCT00004895 - Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery Phase 2
Recruiting NCT02776878 - A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST N/A
Completed NCT01751919 - A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I) Phase 1
Completed NCT01267695 - Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor Phase 2

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