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Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

NCT ID: NCT00338884

Last Updated: 2012-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-04-30

Brief Summary

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A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SUNITINIB MALATE.

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Group Type EXPERIMENTAL

Sunitinib malate

Intervention Type DRUG

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Interventions

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Sunitinib malate

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced kidney cancer

Exclusion Criteria

* Previous treatment for kidney cancer, except surgical removal of kidney tumor
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Adelaide, South Australia, Australia

Site Status

Pfizer Investigational Site

Clayton, Victoria, Australia

Site Status

Pfizer Investigational Site

East Bentleigh, Victoria, Australia

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Taichung, , Taiwan

Site Status

Pfizer Investigational Site

Tainan City, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Argentina Australia Brazil Mexico South Korea Taiwan

References

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de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

Reference Type DERIVED
PMID: 28410911 (View on PubMed)

Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

Reference Type DERIVED
PMID: 27238653 (View on PubMed)

Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

Reference Type DERIVED
PMID: 25577718 (View on PubMed)

Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.

Reference Type DERIVED
PMID: 21898376 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181110&StudyName=Safety%20And%20Effectiveness%20Of%20Daily%20Dosing%20With%2037.5%20mg%20Sunitinib%20Malate%20In%20Patients%20With%20Advanced%20Kidney%20Cancer

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

Other Identifiers

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A6181110

Identifier Type: -

Identifier Source: org_study_id