Phase 1
Completed N=12
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
Carcinoma
Source: ClinicalTrials.gov NCT00447005 ↗
Enrolled (actual)
12
Serious AEs
41.7%
Results posted
Mar 2012
Primary outcomePrimary: Number of Participants With Adverse Events — 12; 5; 7; 0 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
12; 5; 7; 0; 1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax): Single Dose |
29.97 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose |
4 | — |
| SECONDARY Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose |
210.3 | — |
| SECONDARY Terminal Phase Plasma Half-Life (t1/2): Single Dose |
4.8 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax): Multiple Dose |
23.85; 32.14 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose |
3; 4 | — |
| SECONDARY Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose |
137.3; 187.8 | — |
| SECONDARY Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose |
1.449; 1.541 | — |
| SECONDARY Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT) |
-41.73; -40.57; -52.50; -65.48; -0.26; 4.66 | — |
| SECONDARY The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) |
0; 0; 10; 2 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00447005). 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.