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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 2, 2014
Last verified: July 2014
  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. Additionally patients with hematologic malignancies will be evaluated on a treatment schedule of five days in a row with two weeks off.


Condition Intervention Phase
Primary Liver Cancer
Solid Tumors
Lymphoma
AML
ALL
CLL
CML in Accelerated or Blast Phase
Multiple Myeloma
MDS
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: 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 or hematologic malignancies. MRX34 will be administered IV twice a week as a single agent for 3 weeks with 1 week off (total 28 days) or daily x 5 with 2 weeks off (total of 21 days).

  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. For the hematologic malignancy cohorts, patients with AML, ALL, CLL, CML in accelerated or blast phase, lymphoma, MM or MDS may be enrolled
  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. 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. 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
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
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: Cecilia Wilcox       cwilcox@mdanderson.org   
Contact: Brian Herrick       bwherrick@mdanderson.org   
Principal Investigator: David Hong, MD         
Principal Investigator: Jorge Cortes, 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
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         
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         
Sponsors and Collaborators
Mirna Therapeutics, Inc.
Cancer Prevention Research Institute of Texas
Investigators
Study Director: Sinil Kim, MD Mirna Therapeutics
  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: July 2, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Blast Crisis
Liver Neoplasms
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders

ClinicalTrials.gov processed this record on September 14, 2014