Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple My… (NCT02110563) | Clinical Trial Compass
TerminatedPhase 1
Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma
Stopped: Sponsor Decision
United States50 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients, \> 18 years of age at the time of obtaining informed consent.
✓. Patients with a documented solid tumor malignancy that is locally advanced or metastatic; patients with documented multiple myeloma or non-Hodgkin's lymphoma.
✓. Patients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.
✓. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
✓. Dose escalation portion of study: Patients with measurable or non-measurable disease according to standard response criteria .
✓. MTD Biopsy Cohort ONLY: Patients with measurable disease with primary or metastatic tumor site(s) considered safely accessible for biopsy; patients must consent to undergo 2 tumor biopsies.
✓. MTD PNET Cohort ONLY: Patients with advanced (unresectable or metastatic), histologically-confirmed low or intermediate grade PNET according to the World Health Organization (WHO) 2010 classification. Patients with neuroendocrine tumors (e.g., gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary is strongly suspected are also eligible. Patients must also have:
✓
What they're measuring
1
Number of patients with adverse events as a measure of safety and tolerability
Timeframe: Cycle 1 (3 weeks), longer if DRC-MYC is continued; with 30 days follow-up after last dose
Trial details
NCT IDNCT02110563
SponsorDicerna Pharmaceuticals, Inc., a Novo Nordisk company
. Patients with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months.
Exclusion criteria
✕. 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 leukemia (any form) or myelodysplastic syndromes.
✕. MTD PNET Cohort ONLY: Patients with poorly differentiated, high grade (grade 3) neuroendocrine carcinoma, as well as patients with adenocarcinoid, goblet cell carcinoid, or small cell carcinoma, or PNET patients with a Ki-67 proliferation index \> 20 %.
✕. Patients with any of the following hematologic abnormalities at baseline:
✕. Patients with any of the following serum chemistry abnormalities at baseline:
✕. Patients with any of the following coagulation parameter abnormalities at baseline: