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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


N/A
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Neoplasm

Thank you

Trial Information

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


Given that an Expanded Access study does not meet the definition of a controlled clinical
investigation, and as such, is not considered an applicable drug clinical trial per NIH,
Basic Results for such studies are not required to be reported. Protocol A6181036 has been
identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov,
however Basic Results will not be posted.


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.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181036

NCT ID:

NCT00094029

Start Date:

September 2004

Completion Date:

October 2011

Related Keywords:

  • Gastrointestinal Neoplasm
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Stromal Tumors

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteWashington, District of Columbia  20007-2197