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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396148
First received: July 13, 2011
Last updated: June 6, 2017
Last verified: June 2017
July 13, 2011
June 6, 2017
June 25, 2012
July 29, 2019   (Final data collection date for primary outcome measure)
  • Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ]
  • 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 [ Time Frame: Weeks 1-18 ]
  • Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib [ Time Frame: Weeks 1-18 ]
  • Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ]
  • Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ]
  • 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 [ Time Frame: Weeks 1-18 ]
Same as current
Complete list of historical versions of study NCT01396148 on ClinicalTrials.gov Archive Site
  • Objective response rate [ Time Frame: up to 2 years after study enrollment ]
  • Duration of response [ Time Frame: up to 2 years after study enrollment ]
  • Progression-free survival [ Time Frame: up to 2 years after study enrollment ]
  • Overall survival at 2 years after study enrollment [ Time Frame: up to 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 [ Time Frame: up to 2 years after study enrollment ]
  • Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed [ Time Frame: up to 2 years after study enrollment ]
Same as current
Not Provided
Not Provided
 
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: No masking
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.
 
Recruiting
30
July 29, 2019
July 29, 2019   (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: Pfizer CT.gov Call Center 1-800-718-1021
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
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

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