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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396148
First received: July 13, 2011
Last updated: August 12, 2016
Last verified: August 2016
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396148

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Chile
Hospital Luis Calvo Mackenna Centro de Transplante y Oncología Integral (TROI) Recruiting
Providencia, Santiago Rm, Chile, 7500996
Czech Republic
Fakultni nemocnice Brno Recruiting
Brno, Czech Republic, 613 00
FN Brno Recruiting
Brno, Czech Republic, 625 00
Masarykuv onkologicky ustav Recruiting
Brno, Czech Republic, 656 33
France
CHU de La Timone, Hopital enfants Recruiting
Marseille cedex 5, France, 13385
Hopital d'Enfants de la Timone Recruiting
Marseille cedex 5, France, 13385
Hopital de la Timone Recruiting
Marseille cedex 5, France, 13385
Germany
HELIOS Klinikum Berlin-Buch, Klinik für Interdisziplinäre Onkologie Recruiting
Berlin, Germany, 13125
HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13125
Klinikum Stuttgart - Olgahospital, Zentrum für Kinder-, Jugend- und Frauenmedizin Recruiting
Stuttgart, Germany, 70174
Hungary
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika Recruiting
Budapest, Hungary, 1094
India
Tata Memorial Hospital, Department of Peadiatric Medical Oncology Recruiting
Mumbai, Maharashtra, India, 400 012
Rajiv Gandhi Cancer Institute and Research Center Recruiting
Delhi, India, 110 085
Indraprastha Apollo Hospital Recruiting
New Delhi, India, 110 076
Italy
Fondazione IRCCS -Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Azienda Ospedaliera di Padova Not yet recruiting
Padova, Italy, 35128
Mexico
Instituto Nacional De Pediatría Subdireccion de Hemato-Oncología. Recruiting
Mexico, D.f., Mexico, 04530
Norway
Oslo Universitetssykehus Hf Recruiting
Oslo, Norway, 0372
Oslo universitetssykehus HF Recruiting
Oslo, Norway, 0379
Spain
Hospital Infantil Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Turkey
Hacettepe University Faculty of Medicine, Hacettepe Oncology Hospital Recruiting
Ankara, Yenisehir, Turkey, 06100
United Kingdom
The Christie NHS Foundation Trust Recruiting
Withington, Manchester, United Kingdom, M20 4BX
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
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 
Study First Received: July 13, 2011
Last Updated: August 12, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 23, 2016