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NCT01897038 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01897038 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 9 participants.
The verdict
NCT01897038, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Interventions
- DRUG Sorafenib
- DRUG Onartuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01897038
The ClinicalTrials.gov registry entry for NCT01897038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT01897038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01897038 about?
NCT01897038 is a clinical study titled "A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma". This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on ...
What is the current status of trial NCT01897038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01897038?
The interventions under investigation include: Sorafenib (DRUG), Onartuzumab (DRUG).
Who is sponsoring clinical trial NCT01897038?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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