Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan

May 28, 2010 updated by: Novartis Pharmaceuticals

A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors

The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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

  • Japan
      • Tokyo, Japan
        • 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists
  • Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)
  • At least one measurable lesion

Exclusion criteria:

  • Patients with any peripheral neuropathy
  • Patients with unresolved diarrhea
  • Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy

Other protocol-defined inclusion/exclusion criteria may 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPO906
Drug: Patupilone
Other Names:
  • EPO906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting Toxicity
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of patupilone assessed by CTCAE
Time Frame: 18 months
18 months
Pharmacokinetic profile of patupilone
Time Frame: 18 months
18 months
Anti-tumor activity of patupilone according to the RECIST guidelines
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

August 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

May 31, 2010

Last Update Submitted That Met QC Criteria

May 28, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A1103

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.

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