CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
sorafenib tosylate +2 moredrug
Likely dose
sorafenib tosylate 200 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01502410
NCT01502410Phase 2Completed
CompareCT.gov

A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib in Children and Young Adults With Relapsed/Refractory Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma

National Cancer Institute (NCI)·interventional·Posted Dec 30, 2011·Updated Jun 26, 2018

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate, pharmacological study, and 1 other intervention for Childhood Hepatocellular Carcinoma and 6 related conditions. Completed, enrolled 20 participants across 92 sites in 3 countries.

Detailed Summary

This phase II trial studies how well sorafenib tosylate works in treating younger patients with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Hepatocellular Carcinoma, Papillary Thyroid Cancer, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Rhabdomyosarcoma, Recurrent Thyroid Cancer, Recurrent Wilms Tumor and Other Childhood Kidney Tumors
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago

Interventions

sorafenib tosylatedrug

Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological studyother

Optional correlative studies

laboratory biomarker analysisother

Optional correlative studies