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Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00716625
First received: July 15, 2008
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: sunitinib malate
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation For Renal Cell Carcinoma (RCC) Of Sutent (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follow up for safety information. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
sunitinib malate
Patients taking sunitinib malate
 Drug: sunitinib malate

SUTENT® Capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.

The dosage may be decreased according to the patient's clinical condition."

Other Name: Sutent

Detailed Description:

All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.

  Eligibility

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

The patients whom an investigator involving A6181176 prescribes the sunitinib malate (Sutent).

Criteria

Inclusion Criteria:

  • Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered sunitinib malate (Sutent).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716625

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00716625     History of Changes
Other Study ID Numbers: A6181176
Study First Received: July 15, 2008
Last Updated: May 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013