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 MedDRA version: 7.1
Conditions
Interventions
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib malate
CAS Number: 341031-54-7
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Sponsors
Pfizer Global Research and Development
Eligibility
Sex/Gender
All
Inclusion 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 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: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide access to SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol;Secondary Objective: Disease assessments for tumor response and progression will be performed for data collection on selected patients; specifically, 1) patients who previously participated in a study for which objective disease response or time-to-progression was a study endpoint (eg, phase II or III studies) and when the patient had not yet experienced progression while on previous protocol or was assigned to placebo and 2) patients receiving limited duration of treatment in the previous protocol (eg, short-treatment phase I studies;Primary end point(s): 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. | — |
Countries
Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed