Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma
NCT02110563 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-07-11
Summary
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene MYC. MYC oncogene activation is important to the growth of many hematologic and solid tumor malignancies. In this study the Sponsor proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell growth.
Conditions
- Solid Tumors
- Multiple Myeloma
- Non-Hodgkins Lymphoma
- Pancreatic Neuroendocrine Tumors
- PNET
- NHL
Interventions
- DRUG
-
DCR-MYC
Dosing: 2 hour IV infusion on Day 1 and 8 of each 21 day cycle. Starting dose: 0.1mg/kg/dose Dose escalation: 100%, 50%, or 25% increase in subsequent cohorts depending upon toxicity. Number of cycles: until progression or unacceptable toxicity develops.
Sponsors & Collaborators
-
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-10-05
- Completion
- 2016-11-03
Countries
- United States
Study Locations
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