Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00273312

Purpose

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.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Drug: patupilone	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Epothilone B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by Novartis:

Primary Outcome Measures:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures:

Time to progression
Overall survival

Estimated Enrollment:	65
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273312

Locations

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
SUSCF
San Francisco, California, United States, 94115
United States, Connecticut
St. Fancis Hospital and Med Ctr,
Hartford, Connecticut, United States, 06105
United States, New Mexico
Univ of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CEPO906A2213
Study First Received:	January 4, 2006
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00273312
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Advanced unresectable metastatic hepatocellular carcinoma
Liver cancer

Study placed in the following topic categories:

Liver Diseases
Epothilone B
Digestive System Neoplasms
Carcinoma, Hepatocellular
Epothilones
Liver neoplasms
Carcinoma

Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009