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Trial record 1 of 1 for:    NCT03713320
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SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides (SOLAR)

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ClinicalTrials.gov Identifier: NCT03713320
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.

Brief Summary:

The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

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.


Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma/Mycosis Fungoides Drug: Cobomarsen Drug: Vorinostat Phase 2

Detailed Description:

Study Design:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Cobomarsen Drug: Cobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period
Other Name: MRG-106

Active Comparator: Vorinostat Drug: Vorinostat
Daily doses of vorinostat throughout study treatment period




Primary Outcome Measures :
  1. Proportion of subjects achieving an objective skin response of at least 4 months duration (ORR4) [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Based on the modified Severity Weighted Assessment Tool (mSWAT) which measures skin disease severity based on the percentage of skin within each body region with patches, plaques, or tumors. Total scores are calculated by adding the total percent for each category of lesion (patch, plaque, or tumor) and multiplying by a weighting factor. Weighted subtotals are added together to obtain the total score. Lower scores indicate a lower degree of skin disease severity.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of randomization until the date of earliest documented progression or death from any cause

  2. Complete response rate [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Based on mSWAT.

  3. Skin disease severity based on mSWAT [ Time Frame: Monthly up to Week 81, then every other week up to approximately 36 months (estimated study duration) ]
  4. Time to progression [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of randomization until the earliest date of confirmed progression.

  5. Pruritus medication utilization [ Time Frame: From Day 1 to End of Treatment visit, up to approximately 36 months (estimated study duration) ]
  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  7. Plasma concentration of cobomarsen [ Time Frame: From Day 1 to End of Treatment visit, up to approximately 36 months (estimated study duration) ]
    Sparse pharmacokinetic samples will be collected for the purpose of population PK model development and analysis of covariate effects.


Other Outcome Measures:
  1. Number of participants with anti-drug antibody generation [ Time Frame: Up to approximately 36 months (estimated study duration) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Biopsy-proven CTCL, MF subtype
  • 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

Key Exclusion Criteria:

  • Previous enrollment in a cobomarsen study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713320


Locations
Show Show 43 study locations
Sponsors and Collaborators
miRagen Therapeutics, Inc.
Investigators
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Study Director: Diana M. Escolar, MD, FAAN miRagen Therapeutics, Inc.

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Responsible Party: miRagen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03713320    
Other Study ID Numbers: MRG106-11-201
2018-000727-13 ( EudraCT Number )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by miRagen Therapeutics, Inc.:
SOLAR
Cutaneous T-cell Lymphoma
CTCL
Mycosis Fungoides
Lymphoma
Lymphoma, T-cell
Lymphoma, T-cell, cutaneous
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms
MicroRNAs
Vorinostat
Histone Deacetylase Inhibitors
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action