Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Arbutus Biopharma Corporation.
NCT02191878 is a Phase 1 study that has completed, run by Arbutus Biopharma Corporation. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Laboratory assessments
Interventions
- DRUG TKM-080301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02191878 record still lists
NCT02191878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which TKM-080301 is the first listed.
NCT02191878 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02191878's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03726359 · 43 participants · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
- NCT03850418 · 43 participants · Phase 2
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
- NCT04144023 · 43 participants · Phase 1
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
- NCT04176718 · 43 participants · Phase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia