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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03713320




Registration number
NCT03713320
Ethics application status
Date submitted
17/10/2018
Date registered
19/10/2018

Titles & IDs
Public title
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Scientific 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
Secondary ID [1] 0 0
2018-000727-13
Secondary ID [2] 0 0
MRG106-11-201
Universal Trial Number (UTN)
Trial acronym
SOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-Cell Lymphoma/Mycosis Fungoides 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cobomarsen
Treatment: Drugs - Vorinostat

Experimental: 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

Active comparator: 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.


Treatment: Drugs: Cobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period

Treatment: Drugs: Vorinostat
Daily doses of vorinostat throughout study treatment period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
Timepoint [1] 0 0
Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [2] 0 0
Complete Response Rate
Timepoint [2] 0 0
Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [3] 0 0
Time to Progression
Timepoint [3] 0 0
Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [4] 0 0
Time to Maximal Effect in mSWAT
Timepoint [4] 0 0
Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [5] 0 0
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
Timepoint [5] 0 0
Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [6] 0 0
Percentage of Subjects Achieving = 50% Improvement in mSWAT at 28 Days
Timepoint [6] 0 0
28 days after first dose
Secondary outcome [7] 0 0
Percentage of Subjects Achieving = 50% Improvement in mSWAT at 4 Months
Timepoint [7] 0 0
4 months after first dose
Secondary outcome [8] 0 0
Time to = 50% Improvement in mSWAT
Timepoint [8] 0 0
Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [9] 0 0
Duration of Response in Skin
Timepoint [9] 0 0
Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Secondary outcome [10] 0 0
Pruritus Medication Utilization
Timepoint [10] 0 0
Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New York
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United States of America
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Ohio
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Pennsylvania
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Pierre-Bénite
Country [22] 0 0
France
State/province [22] 0 0
Reims
Country [23] 0 0
France
State/province [23] 0 0
Rouen
Country [24] 0 0
Italy
State/province [24] 0 0
Bologna
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Italy
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Milano
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Italy
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Torino
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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United Kingdom
State/province [31] 0 0
Birmingham
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United Kingdom
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Glasgow
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United Kingdom
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London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
miRagen Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Diana M. Escolar, MD, FAAN
Address 0 0
miRagen Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03713320