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

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ClinicalTrials.gov Identifier: NCT02862145
Recruitment Status : Withdrawn (5 immune related serious adverse events in Phase 1 study)
First Posted : August 10, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Mirna Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: MRX34 Drug: Dexamethasone Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Biopsy Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with MRX34
Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
 Drug: MRX34
Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
Other Name: miR-Rx34

Drug: Dexamethasone
Premedication during the week of treatment
Other Name: Decadron


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Frequency and severity of adverse events associated with MRX34 treatment [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Change in tumor measurements over time using RECIST criteria. [ Time Frame: 6 months ]
  2. 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 ]
  3. Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH. [ Time Frame: During 3 months of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862145


Sponsors and Collaborators
Mirna Therapeutics, Inc.
Investigators
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Study Director: Susan Smith, MSN Mirna Therapeutics
More Information
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Responsible Party: Mirna Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02862145    
Other Study ID Numbers: MRX34-102
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mirna Therapeutics, Inc.:
Biosy accessible melanoma
Additional relevant MeSH terms:
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Melanoma
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
Dexamethasone
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents