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

Phase 1

Withdrawn

• Conditions: Melanoma
• Interventions: Drug: MRX34; Drug: Dexamethasone

• Registration Number: NCT02862145
• Lead Sponsor: Mirna Therapeutics, Inc.

Brief Summary

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.

Detailed 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)

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-29
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-06
• Study First Posted: 2016-08-10
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Serious active non-malignant disease
• Central Nervous System metastasis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with MRX34	Dexamethasone	Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
Treatment with MRX34	MRX34	Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.

Primary Outcome Measures

Name	Time	Method
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies	3 months

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events associated with MRX34 treatment	6 months