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Clinical Trial 19729

Cancer Type: Malignant Hematology
Interventions:Cobomarsen; SAHA (Vorinostat); Vorinostat; Zolinza (Vorinostat); suberoylanilide hydroxamic acid (Vorinostat)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Lubomir Sokol

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

This study is to test a new investigational drug (one that is not approved by the US Food and Drug Administration) called cobomarsen (MRG-106). Cobomarsen belongs to a class of drugs called micro-RNA inhibitors and is intended to enter the cancer cells and block the activity of another molecule called miR-155-5p, which may be important for the cancer cells to live and divide. Cobomarsen¿s effect on mycosis fungoides will be compared in this study with the effect of vorinostat, which is a drug that has been approved in the United States and Australia for treatment of CTCL.

Objective

Primary: The primary objective of the study is to evaluate the efficacy of cobomarsen in subjects with MF. Secondary: - Investigate the safety and tolerability of cobomarsen in subjects with MF. - Characterize the population pharmacokinetics (PK) of cobomarsen in subjects with MF. Exploratory: - Characterize pharmacodynamic (PD) effects of cobomarsen.

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
  • Has received at least one prior therapy for Cutaneous T-Cell Lymphoma
  • Other inclusion criteria may apply

  • 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
  • Current evidence of large cell transformation (LCT), defined as > 25% of the lymphocytes at least 4 × the size of normal lymphocytes. Current evidence refers to LCT diagnosis from biopsy performed within 4 months prior to randomization. Subjects with a history of LCT but with a negative current biopsy (within 4 months) are eligible, provided there is no clinical indication for chemotherapy.
  • Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant
  • Visceral involvement related to MF at screening
  • Patients on chronic prophylactic (for prevention, more than 20 days per month) nonsteroidal antipruritic medications within 4 weeks of screening are excluded. Patients on symptomatic (for current symptoms) stable nonsteroidal antipruritic medications (dose and frequency remain the same for at least 1 month prior to screening) for symptomatic pruritus are allowed.
  • Other exclusion criteria may apply