Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01056263
• Collaborator: (none)
• Enrollment: 52
• Locations: 8
• Duration (Months): 8
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 [NCT00076011] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: axitinib: observational study

Detailed Description

Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919]. Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919].

5-year survival information to be updated.

Study Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Time Perspective: Retrospective
• Official Title: Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Non-Interventional Study Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919].	Drug: axitinib: observational study; Non-interventional observational study; Other Names: AG-013736

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [Baseline until death or up to Year 5]

   Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects participating in this observational study originally participated in study A4061012 [NCT00076011] and may have also participated in study A4061008 [NCT00828919]

Exclusion Criteria:

• Subjects who withdrew from the original study A4061012 [NCT00076011] or the continuing access study A4061008 [NCT00828919]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	San Francisco	California	United States	94115
2	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
3	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
4	Pfizer Investigational Site	New York	New York	United States	10065
5	Pfizer Investigational Site	Cleveland	Ohio	United States	44195
6	Pfizer Investigational Site	Madison	Wisconsin	United States	53792
7	Pfizer Investigational Site	Paris Cedex 13		France	75651
8	Pfizer Investigational Site	Hannover		Germany	30625

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01056263
• Other Study ID Numbers: A4061065
• First Posted: Jan 26, 2010
• Last Update Posted: Apr 20, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Pfizer: retrospective trial; 5-year survival; metastatic renal cancer cell
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Axitinib

Study Results

Participant Flow

Arm/Group Title	Axitinib
Arm/Group Description	The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
Period Title: Overall Study
STARTED	52
COMPLETED	0
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	Axitinib
Arm/Group Description	The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
Overall Participants	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (11.3)
Sex: Female, Male (Count of Participants)
Female	12 23.1%
Male	40 76.9%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS)
Description	Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.
Time Frame	Baseline until death or up to Year 5

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).

Arm/Group Title	Axitinib
Arm/Group Description	The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
Measure Participants	52
Median (95% Confidence Interval) [Days]	911.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Axitinib
	Comments	Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Five year survival probability
	Estimated Value	20.60
	Confidence Interval	(2-Sided) 95%; 10.94 to 32.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	There were no adverse events collected in this retrospective study.
Arm/Group Title	Axitinib
Arm/Group Description	The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
All Cause Mortality
	Axitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Axitinib
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Axitinib
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.