Status:
TERMINATED
A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
Lead Sponsor:
Mirna Therapeutics, Inc.
Collaborating Sponsors:
Cancer Prevention Research Institute of Texas
Conditions:
Primary Liver Cancer
SCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 a...
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 unre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01829971
Start Date
April 1 2013
End Date
May 1 2017
Last Update
September 27 2016
Active Locations (10)
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1
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
3
Texas Oncology Dallas
Dallas, Texas, United States, 75246
4
UT Southwestern Medical Center
Dallas, Texas, United States, 75390