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SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Carcinoma

Intervention: Sutent: observational study (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be 1 year.

Clinical Details

Official title: A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of Participants With Categorical Best Overall Response

Number of Participants With Objective Response

Time to Progression (TTP)

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores

Detailed description: The Statistical Analysis Plan provides detailed specification of the analysis

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

- Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Locations and Contacts

Additional Information

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

Starting date: February 2007
Last updated: November 3, 2010

Page last updated: August 23, 2015

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