A TREATMENT PROTOCOL FOR PATIENTS CONTINUING FROM A PRIOR SU011248 PROTOCO
- Conditions
- Patients with any malignancy who have previously been evaluated in a SU011248 protocol
- Registration Number
- EUCTR2005-005335-94-DE
- Lead Sponsor
- Pfizer Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Participated in a previous SU011248 protocol and are judged by the investigator
to have the potential to derive clinical benefit from SU011248 treatment
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. Enrollment within 8 weeks from their last dose of SU011248 or placebo in their
previous 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) yes
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following will not be included in the trial:
1. Current treatment in another clinical trial
2. Pregnancy or breastfeeding
3. 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 judgement of the investigator would make the patient
inappropriate for entry into this study
4. Left ventricular ejection fraction (LVEF) <50% as assessed by MUGA or ECHO
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to provide access to SU011248 treatment for patients who have participated in other SU011248 protocols and have the potential to derive clinical benefit from SU011248 treatment as judged by the investigator.;Secondary Objective: - To assess the safety profile of SU011248<br>- To continue follow-up of efficacy endpoints of interest in previous SU011248 studies contributing to this protocol.;Primary end point(s): Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities;<br>• Overall survival (OS) (for individual patients enrolling from protocols with an overall<br>survival endpoint);<br>• Time to Tumor Progression (TTP) and/or Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors [RECIST]) criteria (for individual patients who previously participated in protocols which include objective response rate (ORR), TTP and/or PFS as a study endpoint).<br>
- Secondary Outcome Measures
Name Time Method