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

Phase 1

Completed

• Conditions: Carcinoma
• Interventions: Drug: Axitinib (AG-013736)

• Registration Number: NCT00447005
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2012-02-25
• Results First Submitted QC: 2012-02-25
• Results First Posted: 2012-03-26
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• Central lung lesions involving major blood vessels
• Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open	Axitinib (AG-013736)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 795 days of treatment plus 28-days follow-up	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 Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax): Single Dose	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose	AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
Terminal Phase Plasma Half-Life (t1/2): Single Dose	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose	t1/2 is the time measured for the plasma concentration to decrease by one half.
Maximum Observed Plasma Concentration (Cmax): Multiple Dose	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose	Dosing Interval was 12 hours in this study.
Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose	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)	Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation	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)	Up to 795 days	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Kashiwa, Chiba, Japan