Clinical trial · Interventional
Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
NCT00828919CI-TRIAL-00083235completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axitinib | Drug | Axitinib | ALIAS |
| crizotinib | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study
- interventionNames
- Drug: axitinib
- Drug: crizotinib
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
- timeFrame
- Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.