Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

Kokeellinen: Avata

Lääke: Axitinib (AG-013736)

AG-013736 5mg twice daily [BID]

Number of Participants With Adverse Events

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.

Maximum Observed Plasma Concentration (Cmax): Single Dose

Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose

Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose

AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).

Terminal Phase Plasma Half-Life (t1/2): Single Dose

t1/2 is the time measured for the plasma concentration to decrease by one half.

Maximum Observed Plasma Concentration (Cmax): Multiple Dose

Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose

Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose

Dosing Interval was 12 hours in this study.

Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose

Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)

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)

Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.

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)

CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.