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A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles
Los Angeles, California, 90027 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Stromal Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-20 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological diagnosis of GIST.

- Patients must have demonstrated either disease progression or intolerance to imatinib
mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain
imatinib in their country.

- Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable
disease.

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

- Current treatment with another investigational agent.

- Prior sunitinib treatment.

- Prior therapy with known risk for cardiovascular complications.

NCT01396148
Pfizer
Completed
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

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A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
  • Drug: sunitinib malate dose escalation
    sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
  • Drug: sunitinib malate
    sunitinib 50mg daily on Schedule 4/2
  • Experimental: Children with GIST
    children ages 6yrs-<18yrs
    Intervention: Drug: sunitinib malate dose escalation
  • Experimental: Young adults with GIST
    young adults ages 18yrs-<21 yrs
    Intervention: Drug: sunitinib malate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
August 21, 2017
August 21, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological diagnosis of GIST.
  • Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
  • Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.

Exclusion Criteria:

  • Current treatment with another investigational agent.
  • Prior sunitinib treatment.
  • Prior therapy with known risk for cardiovascular complications.
Sexes Eligible for Study: All
6 Years to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czechia,   France,   United States
Austria,   Canada,   Chile,   Czech Republic,   Egypt,   Germany,   Hungary,   India,   Italy,   Mexico,   Norway,   Poland,   Portugal,   Singapore,   Slovakia,   Spain,   Turkey,   United Kingdom
 
NCT01396148
A6181196
2011-002008-33 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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