CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2,AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 INCLINICAL TRIALS

• Conditions: Patients who have been treated in previous AG-013736 oncology studies.; MedDRA version: 14.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-000051-15-IT
• Lead Sponsor: PFIZER INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-07
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 39

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 Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start. ? 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

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