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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
Not Enrolling
Both
Hepatocellular Carcinoma

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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 SiteSacramento, California  95817