Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma
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)
1 other identifier
interventional
25
4 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hepatocellular-carcinoma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedFebruary 7, 2017
February 1, 2017
9 months
January 4, 2006
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Time to progression
at screening and at completion of every 6 weeks prior to the next dose administration
Overall survival
at screening and at completion of every 6 weeks prior to the next dose administration
Study Arms (1)
Patupilone
EXPERIMENTALwas administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Novartis Investigative Site
San Francisco, California, 94115, United States
Novartis Investigative Site
Hong Kong, Shatin, NT, Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Seoul, Korea, 110 744, South Korea
Novartis Investigative Site
Seoul, 738-736, South Korea
Novartis Investigative Site
Taipei, Taiwan ROC, 100, Taiwan
Novartis Investigative Site
Tai Chung Municipality, Taiwan
Related 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. Epub 2013 Feb 20.
PMID: 23509629RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
January 1, 2006
Primary Completion
October 1, 2006
Last Updated
February 7, 2017
Record last verified: 2017-02