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

Melanoma Clinical Trial

— MRX34-102  

Official title:

A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02862145
• Other study ID #: MRX34-102
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 29, 2016
• Last updated: September 26, 2016
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Mirna Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• MRX34
Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
• Dexamethasone
Premedication during the week of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mirna Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in tumor measurements over time using RECIST criteria.		6 months	No
Other	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	No
Other	Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH.		During 3 months of treatment	No
Primary	Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies		3 months	No
Secondary	Frequency and severity of adverse events associated with MRX34 treatment		6 months	Yes