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NCT02191878 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma
A Phase 1 study, sponsored by Arbutus Biopharma Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02191878 is a Phase 1 study that has completed, run by Arbutus Biopharma Corporation. The registered enrollment target is 43 participants.
The verdict
NCT02191878, a Phase 1 study, has completed, sponsored by Arbutus Biopharma Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2 expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor activity of intravenous TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC). This study is being done to: * Test the safety and tolerability of TKM-080301 in subjects with advanced hepatocellular carcinoma * Find the highest dose of TKM-080301 that can be given without causing side effects, called the maximum tolerated dose (MTD). * Provide a preliminary assessment of anti-tumor activity of TKM-080301
Interventions
- DRUG TKM-080301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02191878
The ClinicalTrials.gov registry entry for NCT02191878 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arbutus Biopharma Corporation, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TKM-080301 is the first listed.
NCT02191878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02191878 about?
NCT02191878 is a clinical study titled "Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma". This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2 expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor activity of intravenous TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC). This study is being done to: *...
What is the current status of trial NCT02191878?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2014-06. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02191878?
The interventions under investigation include: TKM-080301 (DRUG).
Who is sponsoring clinical trial NCT02191878?
This trial is sponsored by Arbutus Biopharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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