Clinical Trials /

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

NCT01396148

Description:

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.

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT01396148

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Sunitinib</span> In Young Patients With Advanced Gastrointestinal Stromal Tumor

Title

  • Brief Title: A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
  • Official Title: A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

    • Clinical Trial IDs

    NCT ID: NCT01396148

    ORG ID: A6181196

    NCI ID: 2011-002008-33

    Trial Conditions

    Gastrointestinal Stromal Tumors

    Trial Interventions

    Drug Synonyms Arms
    sunitinib malate dose escalation Children with GIST
    sunitinib malate Young adults with GIST

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Children with GIST Experimental children ages 6yrs-<18yrs sunitinib malate dose escalation
    Young adults with GIST Experimental young adults ages 18yrs-<21 yrs sunitinib malate

    Eligibility Criteria

    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.

    Minimum Eligible Age: 6 Years

    Maximum Eligible Age: 20 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662

    Pharmacokinetics- estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) for sunitinib and its active metabolite SU012662

    Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib

    Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662

    Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662

    Pharmacokinetics- Observed area under the plasma concentration versus time curve from time zero to 8 hours post dose (AUC8) for sunitinib and its active metabolite SU012662

    Secondary Outcome Measures

    Objective response rate

    Duration of response

    Progression-free survival

    Overall survival at 2 years after study enrollment

    Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected efficacy parameter (eg, sum of largest diameters for target tumors) is observed

    Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed

    Trial Keywords

    Children and young adults with GIST

    sunitinib malate

    pharmacokinetics

    tumor response

    overall survival

    tumor KIT mutation status