SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
NCT ID: NCT03713320
Last Updated: 2022-04-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
37 participants
INTERVENTIONAL
2019-04-02
2020-12-01
Brief Summary
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Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.
Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
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Detailed Description
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Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cobomarsen
Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter
Cobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period
Vorinostat
Vorinostat will be administered orally at a dose of 400 mg (four 100-mg capsules) once daily with food, at approximately the same time each day.
Vorinostat
Daily doses of vorinostat throughout study treatment period
Interventions
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Cobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period
Vorinostat
Daily doses of vorinostat throughout study treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical stage IB, II, or III, with staging based on screening assessments
* Minimum mSWAT score of 10 at screening
* Receipt of at least one prior therapy for CTCL
Exclusion Criteria
* Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor
* Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening
* Evidence of large cell transformation
* Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant
* Visceral involvement related to MF at screening
18 Years
ALL
No
Sponsors
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miRagen Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Diana M. Escolar, MD, FAAN
Role: STUDY_DIRECTOR
miRagen Therapeutics, Inc.
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California, Irvine
Orange, California, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rochester Skin Lymphoma Medical Group
Fairport, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
University of Washington
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Linear Clinical Research
Nedlands, , Australia
University Clinic UZ Leuven
Leuven, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital Saint André, CHU de Bordeaux
Bordeaux, , France
Hôpital Saint-Louis
Paris, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Hôpital Robert Dubré, CHU de Reims
Reims, , France
Centre Hospitalier Universitaire de Rouen
Rouen, , France
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
AOU Citta dell Salute e della Scienza di Torino
Torino, , Italy
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Fundación Jiménez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Consorcio Hospital General Universitario Valencia
Valencia, , Spain
University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust, Cancer Center
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7.
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-000727-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRG106-11-201
Identifier Type: -
Identifier Source: org_study_id
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