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Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).

- Evidence of unidimensionally measurable disease

- Failure of prior treatment with imatinib or intolerant to imatinib

- Male or female, 18 years of age or older.

- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

- Resolution of all acute toxic effects

- Adequate organ function.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Anticancer treatment after last dose of imatinib

- Major surgery within 4 weeks or radiation therapy within 2 weeks.

- Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.

- Diagnosis of second malignancy within the last 5 years.

- History of brain disease.

- Cardiac disease within 12 months.

- Thyroid function abnormality.

- Ongoing cardiac dysrhythmias.

- Uncontrolled hypertension.

- Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.

- HIV or AIDS related illness.

- Pregnancy or breastfeeding.

NCT00793871
Pfizer
Completed
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

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[email protected]

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Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms
NCT00793871
All Genders
18+
Years
Multiple Sites

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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