Special Investigation For Gist 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:
NCT00716820
First received: July 15, 2008
Last updated: September 8, 2014
Last verified: September 2014
  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
Gastrointestinal Stromal Tumors
Drug: SUNITINIB MALATE

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

Resource links provided by NLM:


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: May 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SUNITINIB MALATE
Patients taking Sutent.
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 A6181175 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
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: NCT00716820

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00716820     History of Changes
Other Study ID Numbers: A6181175
Study First Received: July 15, 2008
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal 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 October 01, 2014