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NCT00273312 Clinical Trial

Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00273312
Other study ID # CEPO906A2213
Secondary ID
Status Completed
Phase Phase 2
First received January 4, 2006
Last updated February 3, 2017
Start date January 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Patupilone
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

Locations
Country Name City State
Hong Kong Novartis Investigative Site Hong Kong Shatin, NT
Hong Kong Novartis Investigative Site Hong Kong
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul
Taiwan Novartis Investigative Site Tai Chung Municipality
Taiwan Novartis Investigative Site Taipei Taiwan ROC
United States Novartis Investigative Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Hong Kong,  Korea, Republic of,  Taiwan, 

References & Publications (1)

Zhou Q, Wong CH, Lau CP, Hui CW, Lui VW, Chan SL, Yeo W. Enhanced Antitumor Activity with Combining Effect of mTOR Inhibition and Microtubule Stabilization in Hepatocellular Carcinoma. Int J Hepatol. 2013;2013:103830. doi: 10.1155/2013/103830. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Time to progression at screening and at completion of every 6 weeks prior to the next dose administration
Secondary Overall survival at screening and at completion of every 6 weeks prior to the next dose administration
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