Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
E7080-G000-201
Study Overview
E7080
lenvatinib
NCT00784303, 2007-005933-12
Nov 2008 - Mar 2019
Thyroid Cancer
1. Objective Response Rate (ORR) [Time Frame: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months]
2. Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) [Time Frame: Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days)]
Males and females 18 Years to 99 Years (Adult, Older Adult)
Completed
Phase
2
Australia, France, Italy, Poland, United Kingdom, United States See moreSee less
The CSR synopses contained on this website are from clinical trials sponsored by Eisai and are provided for informational purposes only. These summaries contain data from the specific study population but do not include the patient-level data from each study participant. The results reported in any single trial may not reflect the overall potential risks or benefits associated with Eisai’s products.
Only health care professionals may determine if a specific product is appropriate as a treatment option for a particular patient. Health care professionals should refer to the specific labelling information approved in their country when making prescribing decisions.
The information provided is not intended to commercialize or promote Eisai’s products for any unapproved uses.
All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of information contained on this website. Eisai reserves the right to amend any information on this website at any time at its sole discretion.
The clinical trial lay summaries contained on this website are from clinical trials sponsored by Eisai and are provided for informational purposes only. These summaries contain data from the specific study population but do not include the patient-level data from each study participant. The results reported in any single trial may not reflect the overall potential risks or benefits associated with Eisai’s products.
Only health care professionals may determine if a specific product is appropriate as a treatment option for a particular patient. Health care professionals should refer to the specific labelling information approved in their country when making prescribing decisions.
The information provided is not intended to commercialize or promote Eisai’s products for any unapproved uses.
All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of information contained on this website. Eisai reserves the right to amend any information on this website at any time at its sole discretion.
If you have questions about the results, please speak with the doctor, research nurse, or other team member at your trial site.
By clicking “Accept” you are acknowledging that you have read and understood this statement.
Schlumberger M, Jarzab B, Cabanillas ME, Robinson B, Pacini F, Ball DW, et al. A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer. CLINICAL CANCER RESEARCH 2016 Jan 01;22(1):44-53. DOI: 10.1158/1078-0432.CCR-15-1127
Data Sharing
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
CSDR Sharing is available for this study.
CSDR
Availability
Clinical Trial Data
Redacted documents may be available upon request for this study.