Hepatocellular Carcinoma
Conditions
Keywords
Advanced unresectable metastatic hepatocellular carcinoma, Liver cancer
Brief summary
This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.
Interventions
DRUGPatupilone
Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | at screening and at completion of every 6 weeks prior to the next dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | at screening and at completion of every 6 weeks prior to the next dose administration |
| Time to progression | at screening and at completion of every 6 weeks prior to the next dose administration |
Countries
Hong Kong, South Korea, Taiwan, United States
Outcome results
None listed