EUCTR2004-001093-11-GB
Active, Not Recruiting
Phase 1
A Treatment Protocol for Patients Continuing from a Prior SU011248 Protocol
Pfizer Global Research and Development0 sitesFebruary 23, 2005
ConditionsThis is an open-label treatment protocol for patients who have participated in other SU011248 protocols to completion and are believed to have the potential to derive clinical benefit from SU011248 treatment. Included in this protocol will be patients assigned to placebo in a previous study who did not qualify for crossover within the original protocol due to declining health status (eg, performance status lower than crossover eligibility criterionMedDRA version: 7.1 Level: LLY Classification code 10062427
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- This is an open-label treatment protocol for patients who have participated in other SU011248 protocols to completion and are believed to have the potential to derive clinical benefit from SU011248 treatment. Included in this protocol will be patients assigned to placebo in a previous study who did not qualify for crossover within the original protocol due to declining health status (eg, performance status lower than crossover eligibility criterion
- Sponsor
- Pfizer Global Research and Development
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all the following inclusion criteria to be eligible for enrollment into the study:
- •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
Exclusion Criteria
- •The presence of any of the following will exclude a patient from study enrollment:
- •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
Outcomes
Primary Outcomes
Not specified
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