Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

NCT00716820 | Completed Results

• 1 other identifier: A6181175
• Study Type: observational
• Target: 472
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  MAX 2 Years

• Objective Response Rate

  Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).

  MAX 2 Years

Secondary Outcomes (9)

• Objective Response Rates by KIT Expression Status

  MAX 2 Years

• Objective Response Rates by c-Kit Mutation Status

  MAX 2 Years

• Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status

  MAX 2 Years

• Number of Participants With Treatment-Related Adverse Events in Elderly Population

  MAX 2 Years

• Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment

  MAX 2 Years

Other Outcomes (3)

• Number of Participants With Treatment-Related Serious Adverse Events

  MAX 2 Years

• Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

  MAX 2 Years

• Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)

  MAX 2 Years

Study Arms (1)

SUNITINIB MALATE

Patients taking Sutent.

Drug: SUNITINIB MALATE

Interventions

SUNITINIB MALATE DRUG

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."

Also known as: SUTENT

SUNITINIB MALATE

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).

You may qualify if:

• Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

You may not qualify if:

• Patients not administered SUNITINIB MALATE(Sutent).

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 6, 2023
• Results First Posted: October 21, 2016

Record last verified: 2023-04