Trials / Completed
CompletedNCT00746317
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
Detailed description
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GC33 | IV administration at 4 escalating dose levels. |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-10-01
- Completion
- 2012-10-01
- First posted
- 2008-09-03
- Last updated
- 2012-10-17
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00746317. Inclusion in this directory is not an endorsement.