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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 : Recruiting
First Posted : October 19, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE September 12, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) [ Time Frame: Up to approximately 36 months (estimated study duration) ]
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) [ Time Frame: Up to 36 months ]
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
Change History Complete list of historical versions of study NCT03713320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • 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
  • Pruritus Numerical Rating Scale [ Time Frame: Daily, up to 6 months, then weekly up to approximately 36 months (estimated study duration) ]
    Measures the patient's degree of itch related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no itch and 10 being worst imaginable itch.
  • Skindex-29 Dermatological Survey [ Time Frame: Monthly, up to approximately 36 months (estimated study duration) ]
    Measures the effects of skin disease on quality of life based on a 30-item questionnaire. The patient's responses are transformed to a linear scale from 0 to 100 and averaged to determine a subscore in three domains (Symptoms, Emotions and Functioning), as well as a total score. Lower scores indicate a lesser degree of skin disease interference with quality of life.
  • Pain Numerical Rating Scale [ Time Frame: Daily, up to 6 months, then weekly up to approximately 36 months (estimated study duration) ]
    Measures the patient's intensity of pain related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no pain and 10 being worst imaginable pain.
  • Difference in drug tolerability by Patient Impression of Treatment Side Effects [ Time Frame: Weekly, up to approximately 36 months (estimated study duration) ]
  • Duration of composite global response for responding subjects [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  • Complete response rate [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
  • Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT) [ Time Frame: Monthly, up to approximately 36 months (estimated study duration) ]
    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.
  • 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.
  • Overall survival [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of randomization until date of death from any cause.
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Progression-free survival [ Time Frame: From date of randomization until the date of progression or death from any cause, up to a maximum of 36 months ]
  • Pruritus Numerical Rating Scale [ Time Frame: Daily, up to a maximum of 36 months ]
  • Skindex-29 [ Time Frame: Monthly, up to a maximum of 36 months ]
  • Pain Numerical Rating Scale [ Time Frame: Daily, up to a maximum of 36 months ]
  • Duration of composite global response for responding subjects [ Time Frame: Up to 36 months ]
  • Complete response rate [ Time Frame: Up to 36 months ]
    Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
  • Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT) [ Time Frame: Monthly, up to a maximum of 36 months ]
  • Time to progression [ Time Frame: From date of randomization until the date of progression, up to a maximum of 36 months ]
  • Overall survival [ Time Frame: From date of randomization until the date of death from any cause, up to a maximum of 36 months ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 36 months ]
  • Plasma concentration of cobomarsen [ Time Frame: From Day 1 to End of Treatment visit, up to a maximum of 36 months ]
    Sparse pharmacokinetic samples will be collected for the purpose of population PK model development and analysis of covariate effects.
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2019)
  • Number of participants with anti-drug antibody generation [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  • Change from baseline in Mycosis Fungoides/Sézary Syndrome Cutaneous T-cell Lymphoma-Quality of Life (MF/SS CTCL QOL) instrument [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Measures the impact of CTCL on patients' quality of life based on a 12-item questionnaire. The patient's total scaled score is determined from the sum of the 12 item scores and may range from 62 to 154. Lower scores indicate a lesser degree of CTCL disease interference with quality of life.
Original Other Pre-specified Outcome Measures
 (submitted: October 17, 2018)
  • Number of participants with anti-drug antibody generation [ Time Frame: Up to 36 months ]
  • Change from baseline in MF/SS CTCL Quality of Life (QOL) instrument [ Time Frame: Up to 36 months ]
 
Descriptive Information
Brief Title  ICMJE SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Official Title  ICMJE 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
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, 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.

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 a separate clinical trial (MRG106-11-203 or PRISM), if they meet the entry criteria for that study.

Detailed Description

Study Design:

Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. A total of 126 subjects (63 per arm) will 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Intervention  ICMJE
  • Drug: Cobomarsen
    At least weekly doses of cobomarsen (282 mg) throughout study treatment period
    Other Name: MRG-106
  • Drug: Vorinostat
    Daily doses of vorinostat throughout study treatment period
Study Arms  ICMJE
  • Experimental: Cobomarsen
    Intervention: Drug: Cobomarsen
  • Active Comparator: Vorinostat
    Intervention: Drug: Vorinostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: miRagen Therapeutics, Inc. +1-720-643-5230 SOLAR@miragen.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713320
Other Study ID Numbers  ICMJE MRG106-11-201
2018-000727-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party miRagen Therapeutics, Inc.
Study Sponsor  ICMJE miRagen Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Diana M. Escolar, MD, FAAN miRagen Therapeutics, Inc.
PRS Account miRagen Therapeutics, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP