A Treatment Protocol for Patients Continuing from Prior SU0011248 Protocol
- Conditions
- Gastrointestinal stromal tumor
- Registration Number
- EUCTR2004-001093-11-ES
- Lead Sponsor
- Pfizer SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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)
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide access to SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol.<br>;Secondary Objective: ;Primary end point(s): The determination of antitumor efficacy during this study will be based on objective tumor assessments made according to the RECIST system of unidimensional evaluation.
- Secondary Outcome Measures
Name Time Method