Back to results

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

Primary Purpose

Melanoma

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MRX34

Dexamethasone

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Biosy accessible melanoma

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with MRX34

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency and severity of adverse events associated with MRX34 treatment

Full Information

NCT ID

NCT02862145

First Posted

July 29, 2016

Last Updated

September 26, 2016

Sponsor

Mirna Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02862145

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Withdrawn

Why Stopped

5 immune related serious adverse events in Phase 1 study

Study Start Date

August 2016 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mirna Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Biosy accessible melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with MRX34

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MRX34

Other Intervention Name(s)

miR-Rx34

Intervention Description

Treatment of melanoma with pharmacodynamics biopsy of tissue and blood

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

Premedication during the week of treatment

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Frequency and severity of adverse events associated with MRX34 treatment

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Change in tumor measurements over time using RECIST criteria.

Time Frame

6 months

Title

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

Time Frame

During 3 months of treatment

Title

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

Time Frame

During 3 months of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Smith, MSN

Organizational Affiliation

Mirna Therapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs