Patients with any malignancy who have previously been evaluated in a SU001248 protocol
Conditions
Interventions
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: range
Concentrati
Sponsors
Pfizer, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Partecipated ina 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
Exclusion criteria
Exclusion criteria: 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 would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide access to SU011248 treatment for patients who have partecipated in other SU011248 protocol and have the potentila to derive clincial benefit from SU011248 tretament as judged by teh investigator.;Secondary Objective: - To assess the safety profile of SU011248 - To continue follow-up of efficacy endpoints of interest in previous SU011248 studies contributing to this protocl.;Primary end point(s): This is an open-label “study . Disease assessments for tumor response and progression will be done for data collection on selected patients ; specifically, patients who previously participated in a study for which objective disease response or time-to-progression was a study endpoint. For individual patients enroling from protocols that included a survival endpoint, follow-up survival information will be collected every 2 months until death or up to 2 years from the date of the last dose of SU011248 | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed