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

Carcinoma Clinical Trial

Official title:

A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447005
• Other study ID #: A4061022
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2007
• Last updated: May 17, 2012
• Start date: February 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma

Intervention

Drug:
• Axitinib (AG-013736)
AG-013736 5mg twice daily [BID]

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Kashiwa	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 795 days of treatment plus 28-days follow-up	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax): Single Dose		Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose	No
Secondary	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	No
Secondary	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).	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose	No
Secondary	Terminal Phase Plasma Half-Life (t1/2): Single Dose	t1/2 is the time measured for the plasma concentration to decrease by one half.	Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose	No
Secondary	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	No
Secondary	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	No
Secondary	Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose	Dosing Interval was 12 hours in this study.	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose	No
Secondary	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)	Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose	No
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)	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.	Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation	No
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)	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.	Up to 795 days	No

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