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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396148
First received: July 13, 2011
Last updated: October 6, 2014
Last verified: October 2014

July 13, 2011
October 6, 2014
June 2012
October 2017   (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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Overall survival at 2 years after study enrollment [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
30
November 2019
October 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.
Both
6 Years to 20 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Italy,   United States,   France,   Canada,   Slovakia,   Czech Republic,   Spain,   Singapore,   Poland,   Egypt,   United Kingdom,   Hungary,   Austria
 
NCT01396148
A6181196, 2011-002008-33
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

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