PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
NCT ID: NCT03837457
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2019-10-01
2020-07-27
Brief Summary
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The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, 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.
Detailed Description
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Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cobomarsen
Cobomarsen
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Interventions
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Cobomarsen
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Evidence of large cell transformation.
* Visceral involvement related to MF at screening.
* Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
* Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
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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Mayo Clinic Hospital
Phoenix, Arizona, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Ohio State University and Wexner Medical Center
Columbus, Ohio, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
University Hospital Leuven
Leuven, , Belgium
Hopital Saint Andre, CHU de Bordeaux
Bordeaux, , France
Hopital Saint-Louis
Paris, , France
Hopital Charles Nicolle, CHU de Rouen
Rouen, , France
Countries
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Other Identifiers
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2018-003748-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRG106-11-203
Identifier Type: -
Identifier Source: org_study_id