Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

NCT ID: NCT01073644

Last Updated: 2013-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.

Detailed Description

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Open label

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sunitinb malate

Sunitinib malate

Intervention Type DRUG

sunitinib 50 mg, 4 weeks on, 2 weeks off

Interventions

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Sunitinib malate

sunitinib 50 mg, 4 weeks on, 2 weeks off

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and above
* Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance

Exclusion Criteria

* Subjects with conditions that are contraindicated with sunitinib malate
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Chong Hua Hospital

Cebu City, , Philippines

Site Status

Private Clinic

Manila, , Philippines

Site Status

Countries

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Philippines

Related Links

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Other Identifiers

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A6181118

Identifier Type: -

Identifier Source: org_study_id

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