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Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cancer Foundation, China
ClinicalTrials.gov Identifier:
NCT01441661
First received: September 26, 2011
Last updated: March 15, 2013
Last verified: September 2007
  Purpose

This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.


Condition
Renal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey

Resource links provided by NLM:


Further study details as provided by Cancer Foundation, China:

Primary Outcome Measures:
  • Disease control rate (DCR) [ Time Frame: 2008-2011 (up to 3 years) ] [ Designated as safety issue: No ]
    • To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS).
    • To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib.


Secondary Outcome Measures:
  • Progression Free survival (PFS) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]
    • To assess the Progression Free survival (PFS) as defined by time interval from date of first dose of Sunitinib to date of the progression of cancer or date of death due to any reasons whichever appears earlier.

  • Overall Survival (OS) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]
    • To evaluate Overall Survival (OS) as defined by time interval from date of first dose of Sunitinib to date of death due to any reason.

  • Number of patients with adverse events [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: Yes ]
    • To evaluate Safety of Sunitinib. Adverse events were graded according to the National Cancer Institute issued the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.


Enrollment: 400
Study Start Date: November 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sunitinib Renal Cell Carcinoma
Patients diagnosed with Renal Cell Carcinoma (RCC) and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.

Detailed Description:

Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with RCC and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.

Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
  • Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria:

  • History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441661

Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
China, Hubei
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Cancer Foundation, China
Pfizer
Investigators
Principal Investigator: Zhangqun Ye, MD Tongji Hospital
  More Information

No publications provided

Responsible Party: Cancer Foundation, China
ClinicalTrials.gov Identifier: NCT01441661     History of Changes
Other Study ID Numbers: CFC20110815
Study First Received: September 26, 2011
Last Updated: March 15, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Cancer Foundation, China:
Sunitinib
kidney diseases
urogenital neoplasms
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014