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

Last updated: September 26, 2016
Sponsor: Mirna Therapeutics, Inc.
Overall Status: Terminated

Phase

1

Condition

Digestive System Neoplasms

Lymphoproliferative Disorders

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT01829971
MRX34-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged ≥ 18 years

  2. Patients with histologically confirmed viral related hepatocellular, SCLC,non-cutaneous/ non-uveal melanoma, ovarian, TNBC, Sarcoma, Bladder and RCC.

  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

  4. Acceptable liver function:

  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); for patients withhepatocellular carcinoma only, total bilirubin ≤ 3 mg/dL (i.e. Child-Pugh Scorefor bilirubin is no greater than 2).

  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkalinephosphatase (ALP) ≤ 5 x ULN.

  1. Acceptable renal function:

• Serum creatinine ≤ 1.5 times the ULN, or calculated creatinine clearance ≥ 60mL/min/1.73 m2 for patients with creatinine levels above 1.5 times the institutionalnormal

  1. Acceptable hematological status:
  • Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3

  • Platelet count ≥ 100,000 plts/mm3 (without transfusion); ≥ 75,000 plts/mm3 forpatients with hepatocellular carcinoma only. For hematologic malignancy patientsblood counts cited above do not apply

  • Hemoglobin ≥ 9 g/dL

  • For the hematologic malignancy patients, blood count values cited above do notapply.

  1. Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN; forpatients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulationparameter); 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 hematologicmalignancy patients, the coagulation and albumin status cited above do not apply

  2. 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 nogreater than 2 and clinically irrelevant; for the determination of the Child-PughClass.

Exclusion

Exclusion Criteria:

  1. Myocardial infarction within the past 6 months, unstable and/or symptomaticarrhythmia, or evidence of ischemia on ECG.

  2. Active, uncontrolled bacterial, viral, or fungal infections requiring systemictherapy.

  3. Pregnant or nursing women.

  4. Known infection with human immunodeficiency virus (HIV).

  5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, orother conditions) that could compromise protocol objectives in the opinion of theinvestigator and/or the sponsor.

  6. Patients with recent history of hemorrhage and patients predisposed to hemorrhage dueto coagulopathies or structural anomalies.

  7. Patients who require treatment with therapeutic doses of coumadin-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 isallowed for patients who require CNS prophylaxis or therapy.

  10. Patients for whom dexamethasone is contraindicated.

Study Design

Total Participants: 155
Study Start date:
April 01, 2013
Estimated Completion Date:
May 31, 2017

Study 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) for 3 cycles followed by a no-treatment observation period.

Connect with a study center

  • Severance Hospital, Yonsie University Health System

    Seoul, Seodaemun-Gu 03722
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Virginia G. Piper Cancer Center

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Texas Oncology Dallas

    Dallas, Texas 75246
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • empty

    Fort Worth, Texas
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Uthscsa/Ctrc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Northwest Cancer Specialist

    Vancouver, Washington 98684
    United States

    Site Not Available

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