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

NCT ID: NCT00412789

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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

Detailed Description

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Conditions

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Tumors

Keywords

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Advanced solid tumor Patupilone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EPO906

Group Type EXPERIMENTAL

Patupilone

Intervention Type DRUG

Interventions

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Patupilone

Intervention Type DRUG

Other Intervention Names

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EPO906

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CEPO906A1103

Identifier Type: -

Identifier Source: org_study_id