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A Phase I, Multicenter Study of MRX34 Given Intravenously Two Times Per Week for Three Weeks, Repeated Every Four Weeks in Patients With Unresectable Primary Liver Cancer or Advanced or Metastatic Cancer With Liver Involvement


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Primary Liver Cancer, Solid Tumors, Lymphoma

Thank you

Trial Information

A Phase I, Multicenter Study of MRX34 Given Intravenously Two Times Per Week for Three Weeks, Repeated Every Four Weeks in Patients With Unresectable Primary Liver Cancer or Advanced or Metastatic Cancer With Liver Involvement


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. MRX34 will be administered IV twice a week for 3 weeks with 1 week off (total
28 days) as a single agent.


Inclusion Criteria:



1. Aged ≥ 18 years

2. Patients with histologically confirmed unresectable primary liver cancer or advanced
metastatic cancer with liver metastasis including lymphoma

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

4. Acceptable liver function:

- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)

- 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 the institutional normal

6. Acceptable hematological status:

- Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3

- Platelet count ≥ 100,000 plts/mm3 (without transfusion)

- Hemoglobin ≥ 9 g/dL

7. Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN.

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 receiving any platelet-inhibiting drugs.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerated dose (MTD) for MRX34 and the recommended phase 2 dose (RPh2D)

Outcome Description:

Dose-limiting toxicity (DLT) in 3-6 patients at the end of one treatment cycle

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Andrew Brenner, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UTHSCSA/CTRC

Authority:

United States: Food and Drug Administration

Study ID:

MRX34-101

NCT ID:

NCT01829971

Start Date:

April 2013

Completion Date:

August 2014

Related Keywords:

  • Primary Liver Cancer
  • Solid Tumors
  • Lymphoma
  • microRNA
  • Primary liver cancer
  • Liver Neoplasms
  • Lymphoma
  • Neoplasm Metastasis

Name

Location

Virginia G. Piper Cancer CenterScottsdale, Arizona  85724
Ut Southwestern Medical CenterDallas, Texas  75390
Uthscsa/CtrcSan Antonio, Texas  78229