Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions

Mirna Therapeutics, Inc.

Overview

This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.

MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Melanoma

Interventions

MRX34DRUG

Treatment of melanoma with pharmacodynamics biopsy of tissue and blood

DexamethasoneDRUG

Premedication during the week of treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years of age * Advanced or metastatic cutaneous, acral or mucosal melanoma * Tumor lesions accessible to serial biopsies * ECOG ≤ 1 * ANC ≥, Plts ≥100,000 /mm3 Exclusion Criteria: * Serious active non-malignant disease * Central Nervous System metastasis

Outcomes

Primary Outcomes

Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies

Time frame: 3 months

Secondary Outcomes

Frequency and severity of adverse events associated with MRX34 treatment

Time frame: 6 months

Data from ClinicalTrials.gov

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