AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00076024

First received: January 12, 2004

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Results First Received: February 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Breast Neoplasms
Interventions:	Drug: Placebo Drug: Docetaxel Drug: AG-013736 (axitinib)

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
Participants who progressed in Docetaxel + Placebo (Phase 2, Double-blind) after consent were eligible to continue to open-label phase. 16 participants crossed-over to open-label phase.

Reporting Groups

	Description
Axitinib + Docetaxel (Phase-1, Lead-in)	Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
Docetaxel + Placebo (Phase 2, Double-blind)	Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
Axitinib (Phase 2, Open-label)	Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.

Participant Flow for 3 periods

Period 1: Phase 1, Lead-in

	Axitinib + Docetaxel (Phase-1, Lead-in)	Axitinib + Docetaxel (Phase 2, Double-blind)	Docetaxel + Placebo (Phase 2, Double-blind)	Axitinib (Phase 2, Open-label)
STARTED	6	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	6	0	0	0
Lack of Efficacy	4	0	0	0
Adverse Event	1	0	0	0
Clinical progression	1	0	0	0

Period 2: Phase 2, Double-blind

	Axitinib + Docetaxel (Phase 2, Double-blind)	Docetaxel + Placebo (Phase 2, Double-blind)
STARTED	112	56
Treated	111	56
COMPLETED	0	0
NOT COMPLETED	112	56
Lack of Efficacy	59	40
Withdrawal by Subject	13	4
Adverse Event	25	6
Un-specified	14	6
Randomized but not treated	1	0

Period 3: Phase 2, Open-label

	Axitinib + Docetaxel (Phase-1, Lead-in)	Axitinib + Docetaxel (Phase 2, Double-blind)	Docetaxel + Placebo (Phase 2, Double-blind)	Axitinib (Phase 2, Open-label)
STARTED	0	0	0	16
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	16
Adverse Event	0	0	0	2
Lack of Efficacy	0	0	0	11
Withdrawal by Subject	0	0	0	1
Unspecified	0	0	0	2

Baseline Characteristics

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Outcome Measures

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1. Primary:

Time to Tumor Progression (TTP) [ Time Frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks ]

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2. Secondary:

Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind) [ Time Frame: Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks ]

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3. Secondary:

Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label) [ Time Frame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks ]

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4. Secondary:

Duration of Response (DR) for Phase 2 (Double-blind) [ Time Frame: Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks ]

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5. Secondary:

Duration of Response (DR) for Phase 2 (Open-label) [ Time Frame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks ]

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6. Other Pre-specified:

Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind) [ Time Frame: Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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
Analysis of TTP (Phase 2, Double-blind) was performed with both discontinuation due to lack of efficacy (LOE) considered a progression and not considered a progression event. Latter was considered primary analysis and former a sensitivity analysis.

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:	NCT00076024 History of Changes
Other Study ID Numbers:	A4061010
Study First Received:	January 12, 2004
Results First Received:	February 25, 2012
Last Updated:	June 21, 2012
Health Authority:	United States: Food and Drug Administration

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