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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 2, 2014
Last verified: July 2014

April 8, 2013
July 2, 2014
April 2013
December 2014   (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 those with liver metastasis from other cancers. The drug is given intravenously, twice per week for three weeks in a row and then one week off. Additionally patients with hematologic malignancies will be evaluated on a treatment schedule of five days in a row with 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 liver involvement or hematologic malignancies. MRX34 will be administered IV twice a week as a single agent for 3 weeks with 1 week off (total 28 days) or daily x 5 with 2 weeks off (total of 21 days).

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Liver Cancer
  • Solid Tumors
  • Lymphoma
  • AML
  • ALL
  • CLL
  • CML in Accelerated or Blast Phase
  • Multiple Myeloma
  • MDS
Drug: MRX34
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
48
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged ≥ 18 years
  2. Patients with histologically confirmed unresectable primary liver cancer or advanced metastatic cancer with liver metastasis. For the hematologic malignancy cohorts, patients with AML, 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.
Both
18 Years and older
No
United States,   Korea, Republic of
 
NCT01829971
MRX34-101
Yes
Mirna Therapeutics, Inc.
Mirna Therapeutics, Inc.
Cancer Prevention Research Institute of Texas
Study Director: Sinil Kim, MD Mirna Therapeutics
Mirna Therapeutics, Inc.
July 2014

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