N/A
Completed N=49
Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
Source: ClinicalTrials.gov NCT00828919 ↗Enrolled (actual)
49
Serious AEs
42.9%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs — 49; 7; 9; 20 Participants
Summary
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs |
49; 7; 9; 20; 2; 11 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00828919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.