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A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposome Injectable Suspension

This study is currently recruiting participants.
Verified October 2013 by Mirna Therapeutics, Inc.
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas (CPRiT)
Information provided by (Responsible Party):
Mirna Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01829971
First received: April 8, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or those with liver metastasis from other cancers. The drug is given intravenously, twice per week for three weeks in a row and then one week off.


Condition Intervention Phase
Primary Liver Cancer
Solid Tumors
Lymphoma
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 Liposome Injectable Suspension

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: One year ] [ Designated as safety issue: Yes ]
    Dose-limiting toxicity (DLT) in 3-6 patients at the end of one treatment cycle


Secondary Outcome Measures:
  • Peak plasma concentration and Area Under the Curve (AUC) of MRX34 after IV dosing [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of patients with evidence of clinical activity of MRX34 [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRX34
Single agent MRX34
Drug: MRX34

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 liver involvement. MRX34 will be administered IV twice a week for 3 weeks with 1 week off (total 28 days) as a single agent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥ 18 years
  2. Patients with histologically confirmed unresectable primary liver cancer or advanced metastatic cancer with liver metastasis including lymphoma
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  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.
    • Hemoglobin ≥ 9 g/dL
  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).
  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. New York Heart Association (NYHA) Class III or IV cardiac disease, 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, 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 coumarin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted).
  8. Patients with cirrhosis classed as Child-Pugh B or C.
  Contacts and Locations
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
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Adrian Avila    214-648-5107    adrian.avila@utsouthwestern.edu   
Principal Investigator: Muhammad Beg, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ashley Herrick, PhD       amherrick@mdanderson.org   
Contact: Brian Herrick       bwherrick@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         
Sponsors and Collaborators
Mirna Therapeutics, Inc.
Cancer Prevention Research Institute of Texas (CPRiT)
Investigators
Principal Investigator: Andrew Brenner, PhD, MD UTHSCSA/CTRC
  More Information

No publications provided

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: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mirna Therapeutics, Inc.:
microRNA
Primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Lymphoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014