Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions (MRX34-102)

Mirna Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Melanoma

Treatments: Drug: MRX34; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02862145

MRX34-102

Details and patient eligibility

About

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.

Full description

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)

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment with MRX34

Experimental group

Description:

Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.

Treatment:

Drug: Dexamethasone

Drug: MRX34