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A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection

This study has been terminated.
(Five immune related serious adverse events)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01829971
First Posted: April 11, 2013
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Mirna Therapeutics, Inc.
  Purpose
This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or other selected solid tumors or hematologic malignancies. The drug is given intravenously, for 5 days in a row and then two weeks off.

Condition Intervention Phase
Primary Liver Cancer SCLC Lymphoma Melanoma Multiple Myeloma Renal Cell Carcinoma NSCLC Drug: MRX34 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection

Resource links provided by NLM:


Further study details as provided by Mirna Therapeutics, Inc.:

Primary Outcome Measures:
  • The maximum tolerated dose (MTD) for MRX34 and the recommended phase 2 dose (RPh2D) [ Time Frame: 18 months ]
    Dose-limiting toxicity (DLT) in 3-6 patients at the end of one treatment cycle


Secondary Outcome Measures:
  • Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing [ Time Frame: 18 months ]
  • Number of patients with evidence of clinical activity of MRX34 [ Time Frame: 18 months ]

Enrollment: 155
Study Start Date: April 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRX34
Single agent MRX34
Drug: MRX34
micro RNA therapy

Detailed Description:
This is a Phase I, open-label, multicenter, dose-escalation study to investigate the safety, Pharmacokinetics and Pharmacodynamics of the micro ribonucleic acid (microRNA) MRX34, in patients with unresectable primary liver cancer or advanced or metastatic cancer with or without liver involvement or hematologic malignancies. MRX34 will be administered daily x 5 with 2 weeks off (total of 21 days) for 3 cycles followed by a no-treatment observation period.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥ 18 years
  2. Patients with histologically confirmed viral related hepatocellular, SCLC, non-cutaneous/ non-uveal melanoma, ovarian, TNBC, Sarcoma, Bladder and RCC.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  4. Acceptable liver function:

    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); for patients with hepatocellular carcinoma only, total bilirubin ≤ 3 mg/dL (i.e. Child-Pugh Score for bilirubin is no greater than 2).
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 5 x ULN.
  5. Acceptable renal function:

    • Serum creatinine ≤ 1.5 times the ULN, or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5 times the institutional normal

  6. Acceptable hematological status:

    • Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3
    • Platelet count ≥ 100,000 plts/mm3 (without transfusion); ≥ 75,000 plts/mm3 for patients with hepatocellular carcinoma only. For hematologic malignancy patients blood counts cited above do not apply
    • Hemoglobin ≥ 9 g/dL
    • For the hematologic malignancy patients, blood count values cited above do not apply.
  7. Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN; for patients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not apply
  8. For patients with hepatocellular carcinoma only, Child-Pugh Class A (score 5-6) disease. Score for hepatic encephalopathy must be 1; the score for ascites must be no greater than 2 and clinically irrelevant; for the determination of the Child-Pugh Class.

Exclusion Criteria:

  1. Myocardial infarction within the past 6 months, unstable and/or symptomatic arrhythmia, or evidence of ischemia on ECG.
  2. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
  3. Pregnant or nursing women.
  4. Known infection with human immunodeficiency virus (HIV).
  5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
  6. Patients with recent history of hemorrhage and patients predisposed to hemorrhage due to coagulopathies or structural anomalies.
  7. Patients who require treatment with therapeutic doses of coumadin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted).
  8. Patients with cirrhosis classed as Child-Pugh B or C.
  9. Patients with central nervous system (CNS) metastasis. Intrathecal chemotherapy is allowed for patients who require CNS prophylaxis or therapy.
  10. Patients for whom dexamethasone is contraindicated.
  Contacts and Locations
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): NCT01829971


Locations
United States, Arizona
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Texas
Texas Oncology Dallas
Dallas, Texas, United States, 75246
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Uthscsa/Ctrc
San Antonio, Texas, United States, 78229
Korea, Republic of
Severance Hospital, Yonsie University Health System
Seoul, Seodaemun-Gu, Korea, Republic of, 03722
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Mirna Therapeutics, Inc.
Cancer Prevention Research Institute of Texas
Investigators
Study Director: O'Neill VIncent, MD Mirna Therapeutics
  More Information

Responsible Party: Mirna Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01829971     History of Changes
Other Study ID Numbers: MRX34-101
First Submitted: April 8, 2013
First Posted: April 11, 2013
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mirna Therapeutics, Inc.:
microRNA
Advanced cancer

Additional relevant MeSH terms:
Multiple Myeloma
Carcinoma, Renal Cell
Liver Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases