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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastrointestinal Stromal Tumors

Intervention: sunitinib malate dose escalation (Drug); sunitinib malate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

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.

Clinical Details

Official title: A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662

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

Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib

Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662

Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662

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

Secondary outcome:

Objective response rate

Duration of response

Progression-free survival

Overall survival at 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

Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed

Eligibility

Minimum age: 6 Years. Maximum age: 20 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

St. Anna Kinderspital GmbH, Vienna, 1090, Austria; Recruiting

Fakultni nemocnice Brno, Brno 613 00, Czech Republic; Recruiting

FN Brno, Brno 625 00, Czech Republic; Recruiting

Masarykuv onkologicky ustav, Brno 656 33, Czech Republic; Recruiting

Nemocnice na Homolce, Praha 5 - Motol 150 30, Czech Republic; Recruiting

Fakultni nemocnice v Motole, Praha 5 150 06, Czech Republic; Recruiting

National Cancer Institute, Cairo, Egypt; Recruiting

Hopital d'Enfants de la Timone, Marseille Cedex 05 13385, France; Recruiting

CHU de La Timone, Hopital enfants, Marseille cedex 5 13385, France; Recruiting

Hopital de la Timone, Marseille cedex 5 13385, France; Recruiting

HELIOS Klinikum Berlin-Buch, Berlin 13125, Germany; Recruiting

HELIOS Klinikum Berlin-Buch, Klinik für Interdisziplinäre Onkologie, Berlin 13125, Germany; Recruiting

Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika, Budapest 1094, Hungary; Recruiting

Rajiv Gandhi Cancer Institute and Research Center, Delhi 110 085, India; Recruiting

Indraprastha Apollo Hospitals, New Delhi 110076, India; Recruiting

Fondazione IRCCS -Istituto Nazionale dei Tumori, Milano 20133, Italy; Recruiting

Azienda Ospedaliera di Padova, Padova 35128, Italy; Recruiting

Oslo universitetssykehus HF, Oslo 0379, Norway; Recruiting

KK Women's and Children's Hospital, Singapore 229899, Singapore; Recruiting

National Cancer Centre, Singapore 169610, Singapore; Recruiting

Detska fakultna nemocnica s poliklinikou Banska Bystrica, Banska Bystrica 97409, Slovakia; Recruiting

Detska fakultna nemocnica s poliklinikou Bratislava, Bratislava 833 40, Slovakia; Recruiting

Detska fakultna nemocnica Kosice, Kosice 040 11, Slovakia; Recruiting

Hospital Universitario Infantil del Niño Jesus, Madrid 28009, Spain; Recruiting

Hospital Infantil Virgen del Rocio, Sevilla 41013, Spain; Recruiting

Hospital Universitari i Politecnic La Fe de Valencia, Valencia 46026, Spain; Recruiting

Hacettepe University Faculty of Medicine, Hacettepe Oncology Hospital, Ankara 06100, Turkey; Recruiting

Hospital Sant Joan de Deu, Esplugues de Llobregat, Barcelona 08950, Spain; Recruiting

Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting

Children's Hospital Colorado/Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States; Not yet recruiting

Instituto Nacional De Pediatría Subdireccion de Hemato-Oncología., Mexico, D.f. 04530, Mexico; Recruiting

University of Miami Hospital and Clinics, Miami, Florida 33136, United States; Not yet recruiting

Tata Memorial Hospital, Department of Medical Oncology, Mumbai, Maharashtra 400 012, India; Recruiting

The Christie NHS Foundation Trust, Withington, Manchester M20 4BX, United Kingdom; Recruiting

Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States; Recruiting

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Not yet recruiting

Hospital Luis Calvo Mackenna Centro de Transplante y Oncología Integral (TROI), Providencia, Santiago, RM 7500996, Chile; Recruiting

The Royal Marsden NHS Foundation Trust,, Sutton, Surrey SM2 5PT, United Kingdom; Recruiting

Primary Children's Medical Center, Salt Lake City, Utah 84113, United States; Not yet recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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