A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
Conditions
Primary Liver Cancer - SCLC - Lymphoma - Melanoma - ALL - CLL - Multiple Myeloma - MDS
Conditions: official terms
Liver Neoplasms - Multiple Myeloma
Conditions: Keywords
microRNA, Primary liver cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MRX34
Type: Drug
Overall Status
Recruiting
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 and then two weeks off.
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Aged ≥ 18 years

2. Patients with histologically confirmed unresectable primary liver cancer or advanced metastatic cancer with or without liver metastasis (melanoma, SCLC, NSCLC). For the hematologic malignancy cohorts, patients with 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.

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.
Locations
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Pamela A McClure - 480-301-4963 - mcclure.pamela@mayo.edu
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Joyce Schaffer, MSN RN AOCNS - 877-273-3713 - joschaffer@shc.org
Texas Oncology Dallas
Dallas, Texas, United States
Status: Not yet recruiting
Contact: Lauren Steckel, BS - lauren.steckel@mckesson.com
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Roberto Torres Martinez - 214-648-5847 - Roberto.TorresMartinez@utsouthwestern.edu
Texas Oncology Fort Worth
Fort Worth, Texas, United States
Status: Recruiting
Contact: Lauren Steckel, BS - lauren.steckel@mckesson.com
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Danxia Ke - DKe@mdanderson.org
Uthscsa/Ctrc
San Antonio, Texas, United States
Status: Recruiting
Contact: Epp Goodwin - 210-450-5798 - goodwine@uthscsa.edu
Northwest Cancer Specialist
Vancouver, Washington, United States
Status: Not yet recruiting
Contact: Lauren Steckel, BS - lauren.steckel@mckesson.com
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Baek-Yeol Ryoo - ryooby@amc.seoul.kr
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Su Jin Lee - ssjj.lee@samsung.com
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Kyung Hun Lee - kyunghunlee@snu.ac.kr
Start Date
April 2013
Completion Date
December 2015
Sponsors
Mirna Therapeutics, Inc.
Source
Mirna Therapeutics, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page