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Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

NCT01070186 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-07-31

No results posted yet for this study

Summary

This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.

Conditions

Interventions

DRUG

Sunitinib

50mg/day for 4 weeks

OTHER

Tumor biopsy

Conducted prior to administration of sunitinib therapy

PROCEDURE

Nephrectomy

Nephrectomy 2-4 weeks after last dose of Sunitinib

OTHER

Biomarkers

Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery. Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Fairooz Kabbinavar, M.D. · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070186 on ClinicalTrials.gov