A Treatment Protocol for Patients Continuing from a Prior SU011248 Protocol

Phase 1

• Conditions: 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 Level: LLY Classification code 10062427

• Registration Number: EUCTR2004-001093-11-GB
• Lead Sponsor: Pfizer Global Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2011-12-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified