Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE) - HOPE

Translational Research Informatics Center, Foundation for Biomedical Research and Innovation0 sites39 target enrollmentJanuary 28, 2016

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Enrollment: 39
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 28, 2016

End Date

December 7, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Translational Research Informatics Center, Foundation for Biomedical Research and Innovation

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) Have complications or medical history of (a) Complication of brain metastasis (Exclude if cured and in clinically stable condition for more than 1 month prior to screening.) (b) Treatment required complication of systemic infectious disease (c) Complication of pulmonary fibrosis or interstitial pneumonitis (d) Medical history of clinically significant cardiovascular disease within 6 months of initial dose as: NYHA class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment e) Uncontrollable complication of diabetes mellitus f) hemoptysis within 3 weeks of enrollment (blood volume of more than half of teaspoon) g) Medical history of hemorrhagic or thrombotic disease within 6 months of enrollment h) If proteinuria values above 2\+ by urinary protein qualitative test, conduct 24\-hour urine collection and the urine protein determined as 1g/24 hours or more. (can substitute to the ratio of proteinuria in morning urine/creatinine) i) Malabsorption at gastrointestinal tract and any of the complication diseases that investigator considers that will be affected to lenvatinib absorption j) Recent major surgery within 2 weeks (if needle biopsy within 1 week) of enrollment k) Drainage required celomic fluid stagnation 2\) Have history of lenvatinib administration 3\) Confirmed tumor invasion to the carotid arteries 4\) Have history of high dose external radiation therapy to cervical region, and irradiated tumor location close to the carotid arteries. 5\) Have any unresolved toxicity greater than 1 by CTCAE v4\.0\. 6\)Have active double cancer 7\) Female patients who are pregnant, lactating, breast feeding or have childbearing potential 8\) Psychiatric disorder and regarded by the investigator as inadequate for this study enrollment 9\) Confirmed as no resistance to any component of this drug 10\) Currently receiving other interventional clinical study treatment