A TREATMENT PROTOCOL FOR PATIENTS CONTINUING FROM A PRIORSU011248 PROTOCO
- Conditions
- This extension protocol will permit continued access to SU011248 for patients who have participated in a previous SU011248 study and who have been judged by the investigator to have the potential to derive clinical benefit from continuing SU011248 dosing.
- Registration Number
- EUCTR2005-005335-94-FR
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the
trial:
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 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) yes
F.1.3.1 Number of subjects for this age range
The presence of any of the following will exclude a patient from study enrollment:
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 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 previous SU011248 protocols and who have the potential to derive clinical benefit from SU011248 treatment as judged by the investigator.;Secondary Objective: To assess the safety of SU011248 administered in the regimens included in this study<br>To continue follow-up of efficacy endpoints of interest in previous SU011248 studies<br>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<br>Evaluation Criteria in Solid Tumors [RECIST]) criteria (for individual patients who<br>previously participated in protocols which include objective response rate (ORR), TTP and/or PFS as a study endpoint)
- Secondary Outcome Measures
Name Time Method