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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003748-22 | EudraCT Number |
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Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
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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 in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). 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 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.
Study Design:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cobomarsen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobomarsen | Drug | At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) | Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT). | Up to approximately 36 months (estimated study duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause. | Up to approximately 36 months (estimated study duration) |
| Pruritis Numerical Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anti-drug antibody generation | Up to approximately 36 months (estimated study duration) |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana M. Escolar, MD, FAAN | miRagen Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Dana-Farber Cancer Institute |
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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.
| Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration) |
| Skindex-29 Dermatological Survey | 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. | Monthly, up to approximately 36 months (estimated study duration) |
| Pain Numerical Rating Scale | 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. | Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration) |
| Difference in drug tolerability by Patient Impression of Treatment Side Effects | Weekly, up to approximately 36 months (estimated study duration) |
| Duration of composite global response for responding subjects | Up to approximately 36 months (estimated study duration) |
| Complete response rate | Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT. | Up to approximately 36 months (estimated study duration) |
| Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT) | 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. | Monthly, up to approximately 36 months (estimated study duration) |
| Time to progression | Time from date of first dose of cobomarsen until the earliest date of confirmed progression. | Up to approximately 36 months (estimated study duration) |
| Overall survival | Time from date of first dose of cobomarsen until the date of death from any cause. | Up to approximately 36 months (estimated study duration) |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to approximately 36 months (estimated study duration) |
| Plasma concentration of cobomarsen | Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen. | Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| The Ohio State University and Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Washington/Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University Hospital Leuven | Leuven | B3000 | Belgium |
| Hopital Saint Andre, CHU de Bordeaux | Bordeaux | 33076 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Charles Nicolle, CHU de Rouen | Rouen | 76031 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 28, 2021 | Aug 20, 2021 | 6 | ||
| Mar 29, 2022 | Apr 25, 2022 | 7 |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000721492 | cobomarsen |
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