EUCTR2004-001093-11-ES
Active, Not Recruiting
N/A
A Treatment Protocol for Patients Continuing from Prior SU0011248 Protocol
ConditionsGastrointestinal stromal tumor
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastrointestinal stromal tumor
- Sponsor
- Pfizer SA
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients must have participated in a previous SU011248 protocol, and are judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician.
- •2\. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •3\. Patients must enroll within 4 weeks from their last End of Cycle visit or their End of
- •Treatment/Withdrawal visit in the previous SU011248 study.
- •4\. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years)
Exclusion Criteria
- •1\. Current treatment in another clinical research trial (other than SU011248\).
- •2\. Symptomatic or uncontrolled CNS metastases.
- •3\. Symptomatic congestive heart failure.
- •4\. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- •5\. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Outcomes
Primary Outcomes
Not specified
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