Neoplasms

All Conditions

Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Axitinib (AG-013736)

Pfizer CT.gov Call Center

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.

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

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.

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

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

Dosing Interval was 12 hours in this study.

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 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.

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.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.

Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred.

AG-013736

Age Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Any adverse events

Any serious adverse events

Any Grade-3 or -4 adverse events

Any Grade-5 adverse events (= death)

Discontinuation due to adverse events

All subjects who received at least 1 dose of the study drug.

Number of Participants With Adverse Events

Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.

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

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

Cycle 1 Day 1 (n=12)

Cycle 1 Day 15 (n=11)

Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.

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

Rac Cmax (n=11)

Rac AUCtau (n=11)

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

s-VEGFR2: Cycle 2 Day 1 (n=12)

s-VEGFR2: At discontinuation (n=11)

s-VEGFR3: Cycle 2 Day 1 (n=12)

s-VEGFR3: At discontinuation (n=11)

s-KIT: Cycle 2 Day 1 (n=12)

s-KIT: At discontinuation (n=11)

VEGF: Cycle 2 Day 1 (n=12)

VEGF: At discontinuation (n=11)

Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.

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)

Participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug (Anti-tumor Response Analysis Set).

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)

Spots Global Cancer Trial Database for Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial