- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862145
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions (MRX34-102)
September 26, 2016 updated by: Mirna Therapeutics, Inc.
A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
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.
Study Overview
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 Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment with MRX34
Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
|
Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
Other Names:
Premedication during the week of treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency and severity of adverse events associated with MRX34 treatment
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in tumor measurements over time using RECIST criteria.
Time Frame: 6 months
|
6 months
|
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
|
During 3 months of treatment
|
Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH.
Time Frame: During 3 months of treatment
|
During 3 months of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susan Smith, MSN, Mirna Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
August 6, 2016
First Posted (Estimate)
August 10, 2016
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- MRX34-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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