Phase Ib/2, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Hepatocellular Carcinoma

Stopped early · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT02314052

Run by

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

People needed

21

Starts

2015-01-27

Expected to finish

2016-10-11

Last updated by the study team

2024-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, > 18 years of age (in Singapore > 21 years or > 18 years with consent of guardian).
• Patients with documented (histologically- or cytologically-proven) HCC, with at least 1 measureable lesion > 10 mm (excluding bone metastases). If the measurable lesion(s) is in the liver, it either should not have been treated previously with loco-regional therapy, or there must be demonstrated progression of the lesion following previous loco-regional therapy.
• Patients with Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
• Patients who are either refractory to or intolerant of sorafenib despite dose reduction and best supportive care, or patients who do not have access to sorafenib or other suitable therapy for HCC.
• Patients with underlying hepatic cirrhosis must have a current cirrhosis status of Child-Pugh Class A (i.e., score of 5-6) without encephalopathy.
• Phase 1b MTD Biopsy Cohort: Patients with primary or metastatic tumor site(s) considered safely accessible for biopsy and consenting to undergo pre- and post-dosing tumor biopsies.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an anticipated life expectancy of ≥ 3 months.
• Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
• Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
• Exclusion Criteria (Patients):
• Women who are pregnant or lactating; women of child-bearing potential (WOCBP), and fertile men with a WOCBP-partner not using and not willing to use a medically effective method of contraception.
• Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
• Patients with mixed histology cholangiocarcinoma and HCC, or fibrolamellar variant HCC.
• Patients with any of the following hematologic abnormalities at baseline:
• Hemoglobin < 8.5 g/dL
• Absolute neutrophil count < 1,500 per mm3
• Platelet count < 75,000 per mm
• Patients with any of the following serum chemistry abnormalities at baseline:
• Total bilirubin > 1.5 × the upper limit of normal (ULN) for the institution
• AST or ALT > 5 × the ULN for the institution
• Serum creatinine > 1.5 × the ULN for the institution
• Patients with the following coagulation parameter abnormality at baseline:
• INR > 1.7 × ULN for the institution
• Patients with:
• A history of deep vein thrombosis (DVT) or pulmonary embolism (PE), within 6 months prior to first study drug administration; patients receiving systemic anti-coagulation for prophylactic or therapeutic reasons

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States
• National University Hospital of Singapore — Singapore, Singapore
• National Cancer Centre Singapore — Singapore, Singapore
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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