Continuing Access to the Tyrosine Kinase Inhibitor of VEGFR-2, AG-013736 (A406) for Patients Previously Receiving AG-013736 in Clinical Trials

Phase 1

• Conditions: Patients who have been treated in previous AG-013736 oncology studies

• Registration Number: EUCTR2005-000051-15-DE
• Lead Sponsor: Pfizer Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-02
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

- Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial

- Patients who were receiving AG-013736 tablets at the time their previous trial ended

- Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease)

- Patients who have progeressive disease (PD), but continue to derive clinical benefit from the treatment with AG-013736 in the investigator's opinion, provided that the sum of diameters (SOD) of measurable lesions are still smaller compared to that at baseline and Pfizer clinician has approved the enrollment.

- Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines

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

Subjects presenting with any of the following will not be included in the trial:

- Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736-containing treatment arm in a previous AG-013736 trial (protocol A4061010, A4061011) and who had documented stable or responding disease at the time they discontinued in the trial. Continuing access will also be provided to patients who have had progressive disease (PD), but who, in the investigator's opinion, continue to derive clinical benefit from the treatment with AG-013736.;Secondary Objective: N/A;Primary end point(s): All patients will be assessed for safety by monitoring adverse events and laboratory values. Response to therapy will not be evaluated.