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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Mirna Therapeutics, Inc.
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Mirna Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01829971
First received: April 8, 2013
Last updated: June 22, 2016
Last verified: June 2016
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Number of patients with evidence of clinical activity of MRX34 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829971

Locations
United States, Arizona
Virginia G. Piper Cancer Center Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN RN AOCNS    877-273-3713    joschaffer@shc.org   
Principal Investigator: Jasgit Sachdev, MD         
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Pamela A McClure    480-301-4963    mcclure.pamela@mayo.edu   
Principal Investigator: Mitesh Borad, MD         
United States, Texas
Texas Oncology Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Crystal Ross       crystal.ross@mckesson.com   
Principal Investigator: Carlos Becerra, MD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Penny Currykosky    214-648-5107    Penny.Currykosky@utsouthwestern.edu   
Principal Investigator: Muhammad Beg, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Danxia Ke       DKe@mdanderson.org   
Principal Investigator: David Hong, MD         
Uthscsa/Ctrc Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-5798    goodwine@uthscsa.edu   
Principal Investigator: Andrew Brenner, MD, PhD         
Korea, Republic of
Severance Hospital, Yonsie University Health System Recruiting
Seoul, Seodaemun-Gu, Korea, Republic of, 03722
Contact: Sang Joon Shin, MD       ssj338@yuhs.ac   
Principal Investigator: Sang Joon Shin, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Hun Lee       kyunghunlee@snu.ac.kr   
Principal Investigator: Tae-You Kim, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Su Jin Lee       ssjj.lee@samsung.com   
Principal Investigator: Ho Yeong Lim, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Baek-Yeol Ryoo       ryooby@amc.seoul.kr   
Principal Investigator: Yoon-Koo Kang, MD         
Principal Investigator: Jae-Lyun Lee, MD,PhD         
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 
Study First Received: April 8, 2013
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration
Korea: Ministry of Food and Drug Safety
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 21, 2016