A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
NCT01262235 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2019-01-16
Summary
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
Conditions
- Cancer
- Neuroendocrine Tumors
- NET
- Adrenocortical Carcinoma
- ACC
Interventions
- DRUG
-
TKM-080301
Repeat dose IV infusion.
Sponsors & Collaborators
-
Arbutus Biopharma Corporation
lead INDUSTRY
Principal Investigators
-
Mark Kowalski, MD · Tekmira Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2015-07-31
- Completion
- 2015-08-31
Countries
- United States
Study Locations
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