A Study In Patients With Advanced Solid Tumor

Neoplasms Clinical Trial

Official title:

A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726752
• Other study ID #: A4061044
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2008
• Last updated: May 17, 2012
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Axitinib (AG-013736)
Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Kobe-shi	Hyogo-ken

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Dose: Maximum Observed Plasma Concentration (Cmax)		Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	No
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)	AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	No
Primary	Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)		Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	No
Primary	Single Dose: Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose	No
Secondary	Multiple Dose: Maximum Observed Plasma Concentration (Cmax)	Cmax at multiple dosing	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	No
Secondary	Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	The dosing interval was 12 hours in this study.	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	No
Secondary	Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)	Tmax at multiple dosing	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	No
Secondary	Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)	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)	Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose	No
Secondary	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 )	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	Prior to the initial dose (baseline) and Day 1 of Cycle 2	No
Secondary	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)	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 470 days	No
Secondary	Number of Participants With Adverse Events	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.	Up to 470 days of treatment plus 28-days follow-up	Yes

External Links

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