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

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NCT00793871

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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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Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Experimental: sunitinib
single agent sunitinib, single arm
Intervention: Drug: Sunitinib Malate (SU011248)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00793871
A6181177
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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