A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)



Status:Active, not recruiting
Conditions:Cancer, Cancer, Endocrine, Thyroid Cancer
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:March 17, 2011
End Date:December 1, 2019

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare
the progression free survival of participants with 131 I -refractory DTC and radiographic
evidence of disease progression within the prior 12 months, 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).

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.

Inclusion criteria:

1. Histologically or cytologically confirmed diagnosis of one of the following DTC
subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC).

2. Measurable disease according to (RECIST 1.1) and confirmed by central radiographic
review.

3. 131 I-refractory/resistant disease.

4. Evidence of disease progression within 12 months prior to signing informed consent (+1
month screening window).

5. Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular
endothelial growth-factor receptors (VEGFR) targeted therapy.

6. Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the
protocol.

Exclusion criteria:

1. Anaplastic or medullary carcinoma of the thyroid

2. 2 or more prior VEGF/ VEGFR-targeted therapies

3. Received any anticancer treatment within 21 days or any investigational agent within
30 days prior to the first dose of study drug.

Inclusion criteria for OOL Lenvatinib Treatment Period :

Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period
if the met the following criteria:

1. Placebo-treated participants in the Randomization Phase who had progressive disease
(PD) confirmed by IIR, and who requested treatment with lenvatinib.

2. Participants who continued to satisfy specified inclusion and exclusion criteria as
presented in the study protocol.

3. Participants with maximum interval between the day of confirmation of PD by IIR and
Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3
months.

4. No systemic anticancer treatment during the interval between the day of confirmation
of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period.
We found this trial at
39
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601 F Street Northwest
Washington, District of Columbia 20004
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Aurora, Colorado 80011
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Baltimore, Maryland
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24282 Huron River Drive
Boston, Michigan 48164
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Boston, Michigan 48164
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1 Center Edgewater Park
Bronx, New York 10465
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Bronx, NY
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6840 North Sacramento Avenue
Chicago, Illinois 60645
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Chicago, IL
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200 East Illinois Street
Chicago, Illinois 60611
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Columbia, Missouri 65202
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555 Borror Drive
Columbus, Ohio 43210
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Detroit, Michigan
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909 Fannin Street
Houston, Texas 77010
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1 North Illinois Street
Indianapolis, Indiana 46204
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4655 Executive Drive
La Jolla, California 92122
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1609 Lake Lansing Road
Lansing, Michigan 48912
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1 Medical Center Drive
Lebanon, New Hampshire 03756
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Lexington, Kentucky
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1 Chenal Heights Drive
Little Rock, Arkansas 72223
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3260 South Bascom Avenue
Los Gatos, California 95124
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4637 North 24th Place
Milwaukee, Wisconsin 53209
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3612 Bloomington Avenue
Minneapolis, Minnesota 55407
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Mission Viejo, California
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Morgantown, West Virginia 26506
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151 Madison Avenue
Morristown, New Jersey 07960
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Neptune, New Jersey 07753
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1 Center Drive
New York, New York 11357
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2 Center Street
New York, New York 10065
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12100-1/2 West Center Road
Omaha, Nebraska 68132
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265 1/2 South Center Street
Orange, California 92866
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2 North Center Street
Orange, California 92866
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315 East Robinson Street
Orlando, Florida 32801
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9880 Bustleton Avenue
Philadelphia, Pennsylvania 19115
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3331 West River Drive
Philadelphia, Pennsylvania 19104
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1 North Center Court Street
Portland, Oregon 97227
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Rosario,
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500 David J Stern Walk
Sacramento, California 95814
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155 Northeast 100th Street
Seattle, Washington 98125
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1 Center Way
Torrance, California 90503
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2625 Executive Park Drive
Weston, Florida 33331
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