Spots Global Cancer Trial Database for Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors
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Trial Identification
Brief Title: Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors
Official Title: A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197) in Children With Relapsed or Refractory Solid Tumors
Study ID: NCT01725191
Conditions
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of tivantinib in treating younger patients with solid tumors that have returned after a period of improvement or have not responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of tivantinib administered orally twice daily to children with refractory solid tumors. II. To define and describe the toxicities of tivantinib administered on this schedule. III. To characterize the pharmacokinetics of tivantinib (capsule as well as powder formulation) in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of tivantinib within the confines of a phase 1 study. II. To preliminarily investigate whether cytochrome P450 (CYP450) polymorphisms impact pharmacokinetics or toxicity of tivantinib. III. To preliminarily investigate whether tumor c-Met and/or hepatocyte growth factor (HGF) expression or downstream c-Met signaling correlate with clinical response to tivantinib. OUTLINE: This is a dose-escalation study. Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Keywords
Eligibility
Minimum Age: 13 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Childrens Hospital of Orange County, Orange, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Columbia University Medical Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Baylor College of Medicine, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: James Geller
Affiliation: COG Phase I Consortium
Role: PRINCIPAL_INVESTIGATOR
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