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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396148
First received: July 13, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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 1/2 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: November 2019
Estimated Primary Completion Date: October 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 21 Years
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 Not yet recruiting
Los Angeles, California, United States, 90027
United States, Colorado
Children's Hospital Colorado/Center for Cancer and Blood Disorders Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami Hospital and Clinics Not yet recruiting
Miami, Florida, United States, 33136
United States, Georgia
Children's Healthcare of Atlanta, Egleston Campus Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, Utah
Primary Children's Medical Center Not yet recruiting
Salt Lake City, Utah, United States, 84113
Austria
St. Anna Kinderspital GmbH Recruiting
Vienna, Austria, 1090
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
CHU Ste-Justine Not yet recruiting
Montreal, Quebec, Canada, H3T 1C5
Czech Republic
Masarykuv onkologicky ustav Recruiting
Brno, Czech Republic, 656 33
Fakultni nemocncie Brno Recruiting
Brno, Czech Republic, 613 00
FN Brno Recruiting
Brno, Czech Republic, 625 00
Fakultni nemocnice v Motole Recruiting
Praha 5, Czech Republic, 150 06
Nemocnice na Homolce Recruiting
Praha 5 - Motol, Czech Republic, 150 30
Egypt
National Cancer Institute Recruiting
Cairo, Egypt
France
Hôpital d'enfants de la Timone Recruiting
Marseille Cedex 05, France, 13385
CHU de La Timone, Hopital enfants Recruiting
Marseille cedex 5, France, 13385
Hopital de la Timone Recruiting
Marseille cedex 5, France, 13385
Hungary
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika Recruiting
Budapest, Hungary, 1094
Italy
Fondazione IRCCS -Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Poland
Klinika Nowotworow Tkanek Miekkich i Kosci Recruiting
Warszawa, Poland, 02-781
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
National Cancer Centre Recruiting
Singapore, Singapore, 169610
Slovakia
Detska fakultna nemocnica s poliklinikou Banska Bystrica Recruiting
Banska Bystrica, Slovakia, 97409
Detska fakultna nemocnica s poliklinikou Bratislava Recruiting
Bratislava, Slovakia, 833 40
Detska fakultna nemocnica Kosice Recruiting
Kosice, Slovakia, 04001
Spain
Hospital Sant Joan de Deu Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Universitario Infantil del Niño Jesus Recruiting
Madrid, Spain, 28009
Hospital Infantil Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
United Kingdom
Paediatric Department, 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396148     History of Changes
Other Study ID Numbers: A6181196
Study First Received: July 13, 2011
Last Updated: July 8, 2014
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
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014