A TREATMENT PROTOCOL FOR PATIENTS CONTINUING FROM A PRIOR SU011248 PROTOCOL - ND

Conditions: Patients with any malignancy who have previously been evaluated in a SU011248 protocol
MedDRA version: 9.1Level: LLTClassification code 10028997Term: Neoplasm malignant

Registration Number: EUCTR2005-005335-94-IT

Lead Sponsor: PFIZER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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 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 Overall survival OS for individual patients enrolling from protocols with an overall survival endpoint 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

Secondary Outcome Measures