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

NCT02862145 | Withdrawn Phase 1 DMC

• 1 other identifier: MRX34-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma

Keywords

Biosy accessible melanoma

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• Frequency and severity of adverse events associated with MRX34 treatment

  6 months

Other Outcomes (3)

• Change in tumor measurements over time using RECIST criteria.

  6 months

• RNA sequencing analysis of PBMCs to evaluate gene expression through TLR signaling, RIG-I Pathway and PD1/PD-L1 Blockade.

  During 3 months of treatment

• Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH.

  During 3 months of treatment

Study Arms (1)

Treatment with MRX34

EXPERIMENTAL

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

Drug: MRX34; Drug: Dexamethasone

Interventions

MRX34 DRUG

Treatment of melanoma with pharmacodynamics biopsy of tissue and blood

Also known as: miR-Rx34

Treatment with MRX34

Dexamethasone DRUG

Premedication during the week of treatment

Also known as: Decadron

Treatment with MRX34

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Mirna Therapeutics, Inc.: lead

MeSH Terms

Conditions

Melanoma

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Susan Smith, MSN

  Mirna Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share