Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT01725191|
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : July 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Childhood Solid Neoplasm||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Tivantinib||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197) in Children With Relapsed or Refractory Solid Tumors|
|Study Start Date :||October 2012|
|Primary Completion Date :||May 2015|
|Study Completion Date :||May 2015|
Experimental: Treatment (tivantinib)
Patients receive tivantinib PO BID on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesDrug: Tivantinib
- MTD defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 28 days ]
- Pharmacokinetic (PK) parameters of tivantinib [ Time Frame: Pre-dose, 1, 2, 4, 6 and 8-12 hours day 1 of course 1; pre-dose day 1 of course 2 ]The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Disease response assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 30 days after completion of study treatment ]Will be reported descriptively.
- CYP450 polymorphisms [ Time Frame: Baseline ]Relationships between CYP450 polymorphisms and pharmacokinetics and toxicity will be explored.
- Tumor c-met expression [ Time Frame: Baseline ]Relationships between tumor c-met expression and response will be explored.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725191
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|Principal Investigator:||James Geller||COG Phase I Consortium|