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

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NCT00793871

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Study Location
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
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.

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Gastrointestinal Neoplasms, Gastrointestinal Stromal TumorsSafety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
NCT00793871
  1. Nanjing, Jiangsu
  2. Beijing,
  3. Beijing,
  4. Bejing,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Official Title  ICMJE 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
Brief Summary To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: sunitinib
single agent sunitinib, single arm
Intervention: Drug: Sunitinib Malate (SU011248)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2008)		60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793871
Other Study ID Numbers  ICMJE A6181177
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP