A Study In Patients With Advanced Solid Tumor

Phase 1

Completed

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

• Registration Number: NCT00726752
• Lead Sponsor: Pfizer

Brief Summary

This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• 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: 6

Inclusion Criteria

• Patients histologically or cytologically diagnosed with advanced solid tumors
• Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
• Patients with no uncontrolled hypertension

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Exclusion Criteria

• Patients who have central lung lesions involving major blood vessels
• Patients who require anticoagulant therapy.
• Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axitinib	Axitinib (AG-013736)	-

Primary Outcome Measures

Name	Time	Method
Single Dose: Maximum Observed Plasma Concentration (Cmax)	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Single Dose: Plasma Decay Half-Life (t1/2)	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Secondary Outcome Measures

Name	Time	Method
Multiple Dose: Maximum Observed Plasma Concentration (Cmax)	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	Cmax at multiple dosing
Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	The dosing interval was 12 hours in this study.
Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	Tmax at multiple dosing
Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour 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 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )	Prior to the initial dose (baseline) and Day 1 of Cycle 2	Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF
Number 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 470 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.
Number of Participants With Adverse Events	Up to 470 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 (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Kobe-shi, Hyogo-ken, Japan