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Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

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

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: SUTENT (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

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

Summary

Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence. The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

Clinical Details

Official title: Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Percentage of Participants With Objective Response

Progression-free Survival (PFS)

Overall Survival (OS)

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12

Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)

Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)

Percentage of Participants With Hypothyroidism

Percentage of Participants With Hypertension

Detailed description: 180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

- No previous cytokines therapy.

Locations and Contacts

Pfizer Investigational Site, Brno 625 00, Czech Republic

Pfizer Investigational Site, Brno 656 53, Czech Republic

Pfizer Investigational Site, Brno 656 91, Czech Republic

Pfizer Investigational Site, Ceske Budejovice 370 87, Czech Republic

Pfizer Investigational Site, Chomutov 430 12, Czech Republic

Pfizer Investigational Site, Hradec kralove 500 05, Czech Republic

Pfizer Investigational Site, Jihlava 586 33, Czech Republic

Pfizer Investigational Site, Karvina 735 06, Czech Republic

Pfizer Investigational Site, Liberec 460 63, Czech Republic

Pfizer Investigational Site, Nova Ves pod Plesi 26204, Czech Republic

Pfizer Investigational Site, Novy Jicin 741 01, Czech Republic

Pfizer Investigational Site, Ostrava 703 84, Czech Republic

Pfizer Investigational Site, Ostrava 708 52, Czech Republic

Pfizer Investigational Site, Pardubice 532 03, Czech Republic

Pfizer Investigational Site, Plzen 301 00, Czech Republic

Pfizer Investigational Site, Praha 5 150 00, Czech Republic

Pfizer Investigational Site, Praha 100 34, Czech Republic

Pfizer Investigational Site, Praha 128 08, Czech Republic

Pfizer Investigational Site, Praha 140 59, Czech Republic

Pfizer Investigational Site, Praha 150 00, Czech Republic

Pfizer Investigational Site, Zlin 639 00, Czech Republic

Additional Information

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

Starting date: June 2008
Last updated: July 17, 2012

Page last updated: August 23, 2015

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