Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
- 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
- Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
Locations & Contacts
Trial Objectives and Outline
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.
Trial Phase & Type
No phase specified
Secondary IDs NCI-2010-02009, 2005-000051-15
Clinicaltrials.gov ID NCT00828919