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NCT01546519 · ClinicalTrials.gov registry record · Phase 1
A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01546519: Completed Phase 1 study, sponsored by Genentech.
NCT01546519 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546519, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard therapy exists.
Primary Outcome
Maximum observed plasma Concentration (Cmax) \& Concentration at steady-state (Css) following multiple doses of vismodegib (150 mg QD) were analyzed. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated. Blood samples for assessing Cmax and Css for analysis were collected following multiple oral doses of vismodegib at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8. From the plasma concentration-time curve, the PK para
Interventions
- DRUG Vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01546519 record still lists
NCT01546519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Vismodegib is the first listed.
NCT01546519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01546519 about?
NCT01546519 is a clinical study titled "A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function". This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard thera...
What is the current status of trial NCT01546519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01546519?
The interventions under investigation include: Vismodegib (DRUG).
Who is sponsoring clinical trial NCT01546519?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01546519's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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
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