Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer - Study Results - ClinicalTrials.gov

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Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

This study is ongoing, but not recruiting participants.

Study NCT00678392 Information provided by Pfizer

First Received on May 12, 2008. Last Updated on April 24, 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: Open Label; Primary Purpose: Treatment
Condition:	Kidney Neoplasms
Interventions:	Drug: Axitinib (AG-013736) Drug: Sorafenib

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
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Reporting Groups

	Description
Axitinib	Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) in cycles of 4 weeks.
Sorafenib	Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.

Participant Flow: Overall Study

	Axitinib	Sorafenib
STARTED	361	362
Treated	359	355
COMPLETED	0	0
NOT COMPLETED	361	362
Adverse Event	1	0
Death	103	102
Withdrawal by Subject	2	4
Protocol Violation	2	0
Lost to Follow-up	3	4
Objective progression or relapse	3	6
Global deterioration of health status	1	0
Unspecified	2	3
Randomized but not treated	2	7
Ongoing	242	236

Baseline Characteristics

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Reporting Groups

	Description
Axitinib	Axitinib (AG-013736) 5 mg tablet administered orally BID in cycles of 4 weeks.
Sorafenib	Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.

Baseline Measures

	Axitinib	Sorafenib	Total
Number of Participants [units: participants]	361	362	723
Age, Customized [units: Participants]
Less than 65 years	238	238	476
Greater than or equal to 65 years	123	124	247
Gender [units: Participants]
Female	96	104	200
Male	265	258	523

Outcome Measures

1. Primary:

Progression-Free Survival (PFS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]

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2. Secondary:

Overall Survival (OS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

3. Secondary:

Percentage of Participants With Objective Response (OR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

4. Secondary:

Duration of Response (DR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

5. Secondary:

Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

6. Secondary:

FKSI-Disease Related Symptoms (FKSI-DRS) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

7. Secondary:

Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: No

8. Secondary:

EQ-5D Visual Analog Scale (EQ-5D VAS) [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ]

Results not yet posted. Anticipated Posting Date: 07/2014 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
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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 by Pfizer

Publications automatically indexed to this study:

Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. Epub 2011 Nov 4.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00678392 History of Changes
Other Study ID Numbers:	A4061032, AXIS TRIAL
Study First Received:	May 12, 2008
Results First Received:	February 25, 2012
Last Updated:	April 24, 2012
Health Authority:	United States: Food and Drug Administration

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