Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injec... | NCT02862145

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

NCT02862145

Sponsor

Mirna Therapeutics, Inc.

Status

Withdrawn

Last Update Posted

Sep 27, 2016Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Melanoma

Interventions

MRX34
Dexamethasone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

5 immune related serious adverse events in Phase 1 study

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Aug 6, 2016

First Posted Date

Aug 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MRX34	Drug	Treatment of melanoma with pharmacodynamics biopsy of tissue and blood	Treatment with MRX34

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Frequency and severity of adverse events associated with MRX34 treatment		6 months

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Susan Smith, MSN	Mirna Therapeutics	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided