Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Pfizer

Status: Completed

Conditions: Solid Tumors

Treatments: Drug: axitinib; Drug: crizotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828919

A4061008

2005-000051-15 (EudraCT Number)

Details and patient eligibility

About

To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

Full description

This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
• Patients who were receiving axitinib (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 axitinib (AG-013736) protocol should be used to determine stable or responding disease).
• Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol

Exclusion criteria

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

Trial design

52 participants in 1 patient group

Treatment

Experimental group

Description:

Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study

Treatment:

Drug: crizotinib

Drug: axitinib