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

Stopped early · Phase 1

Conditions studied: Primary Liver Cancer, SCLC, Lymphoma, Melanoma, Multiple Myeloma, Renal Cell Carcinoma, NSCLC

In brief

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.

Key facts

Study ID

NCT01829971

Run by

Mirna Therapeutics, Inc.

People needed

155

Starts

2013-04-01

Expected to finish

2017-05-01

Last updated by the study team

2016-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Myocardial infarction within the past 6 months, unstable and/or symptomatic arrhythmia, or evidence of ischemia on ECG.
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
• Pregnant or nursing women.
• Known infection with human immunodeficiency virus (HIV).
• 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.
• Patients with recent history of hemorrhage and patients predisposed to hemorrhage due to coagulopathies or structural anomalies.
• Patients who require treatment with therapeutic doses of coumadin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted).
• Patients with cirrhosis classed as Child-Pugh B or C.
• Patients with central nervous system (CNS) metastasis. Intrathecal chemotherapy is allowed for patients who require CNS prophylaxis or therapy.
• Patients for whom dexamethasone is contraindicated.

Where it is running

• Virginia G. Piper Cancer Center — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Texas Oncology Dallas — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Uthscsa/Ctrc — San Antonio, Texas, United States
• Severance Hospital, Yonsie University Health System — Seoul, Seodaemun-Gu, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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