NCT01056263

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 28, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

January 25, 2010

Results QC Date

February 25, 2012

Last Update Submit

April 18, 2012

Conditions

Carcinoma, Renal Cell

Keywords

retrospective trial5-year survivalmetastatic renal cancer cell

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    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.

    Baseline until death or up to Year 5

Study Arms (1)

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

Interventions

axitinib: observational studyDRUG

Non-interventional observational study

Also known as: AG-013736
Non-Interventional Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

New York, New York, 10065, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Hanover, 30625, Germany

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 20, 2012

Results First Posted

March 28, 2012

Record last verified: 2012-04

Locations

US(6)FR(1)DE(1)