ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

This study is currently recruiting participants.
Verified by Pfizer, July 2008

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00094029
  Purpose

The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.


Condition Intervention Phase
Gastrointestinal Neoplasm
Drug: SU011248
Phase III

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Sunitinib    Sunitinib malate    Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Tumor Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   1400
Study Start Date:   September 2004
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
sunitinib: Experimental
sutent, 25, 37.5, or 50 mg daily
Drug: SU011248
sutent, 25, 37.5, or 50 mg daily

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
  • Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
  • Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
  • Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
  • Male or Female, 18 years or older
  • Resolution of all acute toxicities of prior therapies
  • Adequate organ function

Exclusion Criteria:

  • Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
  • Symptomatic central nervous system metastases
  • Serious acute or chronic illness
  • Current treatment on another clinical trial
  • Pregnant or breastfeeding.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094029

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service     1-877-369-9753     PfizerCancerTrials@emergingmed.com    

Show 115 study locations  Show 115 Study Locations

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:   A6181036
First Received:   October 8, 2004
Last Updated:   July 2, 2008
ClinicalTrials.gov Identifier:   NCT00094029
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Imatinib
Digestive System Diseases
Digestive System Neoplasms
Sunitinib
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers