A Study In Patients With Advanced Solid Tumor

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00726752

First received: July 30, 2008

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Results First Received: February 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Neoplasms
Intervention:	Drug: Axitinib (AG-013736)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
AG-013736	Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Description

AG-013736

Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Participant Flow: Overall Study

	AG-013736
STARTED	6
COMPLETED	0
NOT COMPLETED	6
Lack of Efficacy	6

Baseline Characteristics

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Reporting Groups

	Description
AG-013736	Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Description

AG-013736

Baseline Measures

	AG-013736
Number of Participants [units: participants]	6
Age [units: years] Mean ± Standard Deviation	53.8 ± 15.8
Gender [units: participants]
Female	3
Male	3

Outcome Measures

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1. Primary:

Single Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

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Measure Type	Primary
Measure Title	Single Dose: Maximum Observed Plasma Concentration (Cmax)
Measure Description	No text entered.
Time Frame	Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.

Reporting Groups

	Description
AG-013736	Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.

Description

AG-013736

Measured Values

	AG-013736
Number of Participants Analyzed [units: participants]	6
Single Dose: Maximum Observed Plasma Concentration (Cmax) [units: ng/mL] Mean ± Standard Deviation
5 mg Single Dose	20.732 ± 14.492
7 mg Single Dose	32.007 ± 28.223
10 mg Single Dose	53.123 ± 60.921

No statistical analysis provided for Single Dose: Maximum Observed Plasma Concentration (Cmax)

2. Primary:

Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

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3. Primary:

Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

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4. Primary:

Single Dose: Plasma Decay Half-Life (t1/2) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]

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5. Secondary:

Multiple Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

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6. Secondary:

Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

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7. Secondary:

Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

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8. Secondary:

Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]

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9. 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 ) [ Time Frame: Prior to the initial dose (baseline) and Day 1 of Cycle 2 ]

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10. 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) [ Time Frame: Up to 470 days ]

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11. Secondary:

Number of Participants With Adverse Events [ Time Frame: Up to 470 days of treatment plus 28-days follow-up ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00726752 History of Changes
Other Study ID Numbers:	A4061044
Study First Received:	July 30, 2008
Results First Received:	February 25, 2012
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

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