A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

Clinical Trial Description

Randomization Phase: Participants will receive blinded study drug (lenvatinib/placebo) in 2:1 ratio until documentation of disease progression (confirmed by independent imaging review), development of unacceptable toxicity, or withdrawal of consent. After having completed the primary analysis, subjects treated with lenvatinib who have not experienced disease progression may request to continue open label lenvatinib at the same dose, according to the clinical judgment of the investigator. Participants who discontinue treatment for any reason other than disease progression will be followed in the Randomization Phase until disease progression or start of another anticancer treatment; these participants then enter the Extension Phase for survival follow-up. Extension Phase: Participants in the placebo arm who have disease progression confirmed by IIR could request to enter the OOL Lenvatinib Treatment Period and receive lenvatinib treatment. Participants will receive lenvatinib treatment until disease progression (investigator's assessment), development of intolerable toxicity, or withdrawal of consent. Participants who had disease progression during the Randomization Phase and did not enter the OOL Lenvatinib Treatment Period and all participants who discontinued lenvatinib treatment in the OOL Lenvatinib Treatment Period will enter the follow-up period. Participants will be followed for survival, and all anticancer treatments will be recorded until the time of death. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01321554
Study type	Interventional
Source	Eisai Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	March 17, 2011
Completion date	March 19, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05774535` - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn	`NCT04224792` - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors	N/A
Completed	`NCT01728623` - A Study of E7080 in Subjects With Advanced Thyroid Cancer	Phase 2
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02911155` - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting	`NCT05025046` - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting	`NCT03978351` - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed	`NCT02658513` - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Withdrawn	`NCT01994200` - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	Phase 1/Phase 2
Completed	`NCT02375451` - Effect of Childhood Radioiodine Therapy on Salivary Function	N/A
Terminated	`NCT01403324` - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer	N/A
Completed	`NCT00970359` - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244	N/A
Completed	`NCT00439478` - Dental Safety Profile of High-Dose Radioiodine Therapy	Phase 4
Completed	`NCT00223158` - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer	N/A
Active, not recruiting	`NCT04544111` - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	Phase 2
Completed	`NCT04876287` - Salivary dysfuncTion After Radioiodine Treatment
Recruiting	`NCT06073223` - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer	N/A
Recruiting	`NCT06037174` - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting	`NCT04952493` - Anlotinib or Penpulimab in Combination With RAI for DTC	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) — SELECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms