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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 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: June 22, 2016
Last verified: June 2016

April 8, 2013
June 22, 2016
April 2013
March 2017   (final data collection date for primary outcome measure)
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
To determine the maximum tolerated dose (MTD) for MRX34 and the recommended phase 2 dose (RPh2D) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Dose-limiting toxicity (DLT) evaluation in 3-6 patients at the end of one treatment cycle
Complete list of historical versions of study NCT01829971 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the pharmacokinetic (PK) profile of MRX34 after IV dosing [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To assess the clinical activity of MRX34 [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Liver Cancer
  • SCLC
  • Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Renal Cell Carcinoma
  • NSCLC
Drug: MRX34
micro RNA therapy
Experimental: MRX34
Single agent MRX34
Intervention: Drug: MRX34
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2017
March 2017   (final data collection date for primary outcome measure)

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 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. 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, heart 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 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 is allowed for patients who require CNS prophylaxis or therapy.
  10. Patients for whom dexamethasone is contraindicated.
Both
18 Years and older   (Adult, Senior)
No
United States,   Korea, Republic of
 
NCT01829971
MRX34-101
Yes
No
Not Provided
Mirna Therapeutics, Inc.
Mirna Therapeutics, Inc.
Cancer Prevention Research Institute of Texas
Study Director: O'Neill VIncent, MD Mirna Therapeutics
Mirna Therapeutics, Inc.
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP