An Open-label, Phase II Trial of Patupilone (EPO906) as Monotherapy to Evaluate Activity of Patupilone in Patients With Advanced Unresectable and/or Metastatic Hepatocellular Carcinoma (HCC)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
An Open-label, Phase II Trial of Patupilone (EPO906) as Monotherapy to Evaluate Activity of Patupilone in Patients With Advanced Unresectable and/or Metastatic Hepatocellular Carcinoma (HCC)
Inclusion Criteria
Inclusion criteria:
- Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable
lesion without any systemic single agent or combination chemotherapy. Previous local
therapy is allowed.
Exclusion criteria:
Additional protocol-defined inclusion/exclusion criteria apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome Time Frame:
at screening and at completion of every 6 weeks prior to the next dose administration
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CEPO906A2213
NCT ID:
NCT00273312
Start Date:
January 2006
Completion Date:
Related Keywords:
- Hepatocellular Carcinoma
- Advanced unresectable metastatic hepatocellular carcinoma
- Liver cancer
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Novartis Investigative Site | Sacramento, California 95817 |
