Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

February 3, 2017 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
    • Shatin, NT
      • Hong Kong, Shatin, NT, Hong Kong
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 738-736
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
  • Taiwan
      • Tai Chung Municipality, Taiwan
        • Novartis Investigative Site
    • Taiwan ROC
      • Taipei, Taiwan ROC, Taiwan, 100
        • Novartis Investigative Site
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patupilone
was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks
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
Other Names:
  • EPO906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at screening and at completion of every 6 weeks prior to the next dose administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: at screening and at completion of every 6 weeks prior to the next dose administration
at screening and at completion of every 6 weeks prior to the next dose administration
Overall survival
Time Frame: at screening and at completion of every 6 weeks prior to the next dose administration
at screening and at completion of every 6 weeks prior to the next dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (ESTIMATE)

January 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Patupilone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe