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Spots Global Cancer Trial Database for A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

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Trial Identification

Brief Title: A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Official Title: A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

Study ID: NCT02702388

Conditions

Thyroid Cancer

Study Description

Brief Summary: This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

Detailed Description: This study consists of 2 phases, the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will last no longer than 28 days and will include a Screening Period to establish protocol eligibility and a Baseline Period to confirm eligibility and establish disease characteristics prior to randomization and treatment. The Randomization Phase will consist of a Treatment Period and a Follow-up Period. It will begin at the time of randomization of the first participant and will consist of 28-day blinded study treatment cycles. The data cutoff for the primary analysis will occur at the end of the Randomization Phase, which is defined as when the last participant enrolled completes the Week 24 tumor assessments or discontinues study treatment if before Week 24. Participants on treatment at the time of data cutoff for the primary analysis will remain on blinded investigational product until the primary analysis has been completed, after which they will transition to commercial lenvatinib outside the study. The last participant's last assessment (Off-treatment visit) will be the End of Study. Participants will be randomly assigned to treatment with 1 of 2 blinded starting dosages of lenvatinib in a 1:1 ratio to receive lenvatinib 18 mg or 24 mg orally once daily (QD). Dose reductions will occur in succession based on the previous dose level (24, 20, 14, 10, and 8 mg QD, or 18, 14, 10, 8, and 4 mg QD, respectively). Once the dose has been reduced, it may not be increased at a later date.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Facility#1, La Jolla, California, United States

Facility #1, San Diego, California, United States

Facility #1, Torrance, California, United States

Facility #1, Washington, District of Columbia, United States

Facility #1, Boston, Massachusetts, United States

Facility #2, Boston, Massachusetts, United States

Facility #1, Ann Arbor, Michigan, United States

Facility #1, Detroit, Michigan, United States

Facility#2, Morristown, New Jersey, United States

Facility#1, Summit, New Jersey, United States

Facility #1, Bronx, New York, United States

Facility #1, Columbus, Ohio, United States

Facility #1, Portland, Oregon, United States

Facility #2, Philadelphia, Pennsylvania, United States

Facility #1, Philadelphia, Pennsylvania, United States

Facility #1, Seattle, Washington, United States

Facility #1, Darlinghurst, New South Wales, Australia

Facility #1, Saint Leonards, New South Wales, Australia

Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia

Facility#2, Chermside, Queensland, Australia

Facility #1, Herston, Queensland, Australia

Facility #1, Melbourne, Victoria, Australia

Facility #1, Nedlands, Western Australia, Australia

Facility #1, Melbourne, , Australia

Facility #1, Saint Leonards, , Australia

Facility #1, Edegem, Antwerpen, Belgium

Facility #1, Bruxelles, Brussels, Belgium

Facility #2, Namur, , Belgium

Facility #1, Namur, , Belgium

Facility #1, Calgary, Alberta, Canada

Facility #1, Toronto, Ontario, Canada

Facility #1, Quebec, , Canada

Facility #1, Odense, Syddanmark, Denmark

Facility #1, Strasbourg, Bas-Rhin, France

Facility #1, Caen, Calvados, France

Facility #1, Dijon, Cote-d'Or, France

Facility #1, Bordeaux, Gironde, France

Facility #1, Angers, Maine-et-Loire, France

Facility #2, Villejuif, Val-de-Marne, France

Facility #1, Villejuif, Val-de-Marne, France

Facility #2, Angers, , France

Facility #1, Bordeaux, , France

Facility #1, Caen, , France

Facility #1, Dijon, , France

Facility #2, Lyon, , France

Facility #1, Paris, , France

Facility #1, Tubingen, Baden-Wurttemberg, Germany

Facility #1, Wurzburg, Bayern, Germany

Facility #1, Hannover, Niedersachsen, Germany

Facility #1, Essen, Nordrhein-Westfalen, Germany

Facility #2, Essen, Nordrhein-Westfalen, Germany

Facility #1, Essen, , Germany

Facility #1, Leipzig, , Germany

Facility #1, Petach Tikva, , Israel

Facility #6, Roma, Lazio, Italy

Facility #1, Roma, Lazio, Italy

Facility #2, Roma, Lazio, Italy

Facility #3, Roma, Lazio, Italy

Facility #2, Milano, Lombardia, Italy

Facility #3, Milano, Lombardia, Italy

Facility #4, Milano, Lombardia, Italy

Facility #5, Milano, Lombardia, Italy

Facility #1, Livorno, Toscana, Italy

Facility #1, Pisa, Toscana, Italy

Facility #6, Milano, , Italy

Facility #7, Milano, , Italy

Facility #2, Pisa, , Italy

Facility #4, Roma, , Italy

Facility #2, Rozzano, , Italy

Facility #1, Torino, , Italy

Facility #1, Viagrande, , Italy

Facility#1, Busan, , Korea, Republic of

Facility #1, Goyang-si, , Korea, Republic of

Facility #3, Seoul, , Korea, Republic of

Facility #4, Seoul, , Korea, Republic of

Facility #1, Seoul, , Korea, Republic of

Facility #2, Seoul, , Korea, Republic of

Facility #2, Kielce, , Poland

Facility #1, Cluj-Napoca, Cluj, Romania

Facility #1, Bucharest, , Romania

Facility #4, Saint Petersburg, Leningradskaya O, Russian Federation

Facility #3, Moscow, , Russian Federation

Facility #4, Moscow, , Russian Federation

Facility #1, Moscow, , Russian Federation

Facility #2, Moscow, , Russian Federation

Facility #1, Obninsk, , Russian Federation

Facility #3, Saint Petersburg, , Russian Federation

Facility #1, Saint Petersburg, , Russian Federation

Facility #2, Saint Petersburg, , Russian Federation

Facility #1, Barcelona, Cataluna, Spain

Facility #2, Madrid, Madrid, Communidad Delaware, Spain

Facility #1, Badalona, , Spain

Facility #2, Barcelona, , Spain

Facility #1, Madrid, , Spain

Facility #2, Madrid, , Spain

Facility #3, Madrid, , Spain

Facility #1, Malaga, , Spain

Facility #1, Goteborg, , Sweden

Facility #1, Lund, , Sweden

Facility #1, London, City Of London, United Kingdom

Facility #1, Glasgow, Glasgow City, United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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