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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396148
First Posted: July 18, 2011
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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.

Condition Intervention Phase
Gastrointestinal Stromal Tumors Drug: sunitinib malate dose escalation Drug: sunitinib malate Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Actual Study Start Date: June 25, 2012
Study Completion Date: August 21, 2017
Primary Completion Date: August 21, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Children with GIST
children ages 6yrs-<18yrs
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).
Experimental: Young adults with GIST
young adults ages 18yrs-<21 yrs
Drug: sunitinib malate
sunitinib 50mg daily on Schedule 4/2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396148


Locations
United States, California
Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Czechia
Dr. Viera Bajciova, Fakultni nemocnice Brno
Brno, Czechia, 613 00
FN Brno
Brno, Czechia, 625 00
Masarykuv onkologicky ustav
Brno, Czechia, 656 33
France
CHU de La Timone, Hopital enfants
Marseille cedex 5, France, 13385
Hopital d'Enfants de la Timone
Marseille cedex 5, France, 13385
Hopital de la Timone
Marseille cedex 5, France, 13385
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396148     History of Changes
Other Study ID Numbers: A6181196
2011-002008-33 ( EudraCT Number )
First Submitted: July 13, 2011
First Posted: July 18, 2011
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Pfizer:
Children and young adults with GIST
sunitinib malate
pharmacokinetics
tumor response
overall survival
tumor KIT mutation status

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors