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

Last updated on November 15, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Official Title  ICMJE A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
Brief SummaryChildren 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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: October 4, 2017)
6
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2011)
30
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion DateAugust 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   United States
Removed Location CountriesAustria,   Canada,   Chile,   Czech Republic,   Egypt,   Germany,   Hungary,   India,   Italy,   Mexico,   Norway,   Poland,   Portugal,   Singapore,   Slovakia,   Spain,   Turkey,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01396148
Other Study ID Numbers  ICMJE A6181196
2011-002008-33 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

ICMJE     Data element required by the

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

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