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Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Patupilone
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Advanced unresectable metastatic hepatocellular carcinoma, Liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patupilone

Arm Description

was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks

Outcomes

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

Full Information

First Posted
January 4, 2006
Last Updated
February 3, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00273312
Brief Title
Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Advanced unresectable metastatic hepatocellular carcinoma, Liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patupilone
Arm Type
Experimental
Arm Description
was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Patupilone
Other Intervention Name(s)
EPO906
Intervention Description
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
Primary Outcome Measure Information:
Title
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
at screening and at completion of every 6 weeks prior to the next dose administration
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
at screening and at completion of every 6 weeks prior to the next dose administration
Title
Overall survival
Time Frame
at screening and at completion of every 6 weeks prior to the next dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Novartis Investigative Site
City
Hong Kong
State/Province
Shatin, NT
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
738-736
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
Taiwan ROC
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tai Chung Municipality
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23509629
Citation
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. Epub 2013 Feb 20.
Results Reference
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Learn more about this trial

Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

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