Clinical trial · Interventional
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
NCT00447005CI-TRIAL-00006967completedPhase 1Results 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 evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
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 |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib (AG-013736) | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open
- interventionNames
- Drug: Axitinib (AG-013736)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- Up to 795 days of treatment plus 28-days follow-up
- description
- Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.
Secondary outcomes (10)
- measure
- Maximum Observed Plasma Concentration (Cmax): Single Dose
- timeFrame
- Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients histologically or cytologically diagnosed with advanced malignant solid tumors * Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies Exclusion Criteria: * Central lung lesions involving major blood vessels * Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
References
Publications (1)
- DERIVEDMukohara T, Nakajima H, Mukai H, Nagai S, Itoh K, Umeyama Y, Hashimoto J, Minami H. Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients. Cancer Sci. 2010 Apr;101(4):963-8. doi: 10.1111/j.1349-7006.2009.01465.x. Epub 2009 Dec 9. PMID 20180805