NCT00412789

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

1.4 years

First QC Date

December 15, 2006

Last Update Submit

May 28, 2010

Conditions

Tumors

Keywords

Advanced solid tumorPatupilone

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting Toxicity

    18 months

Secondary Outcomes (3)

  • Safety and tolerability of patupilone assessed by CTCAE

    18 months

  • Pharmacokinetic profile of patupilone

    18 months

  • Anti-tumor activity of patupilone according to the RECIST guidelines

    18 months

Study Arms (1)

EPO906

EXPERIMENTAL
Drug: Patupilone

Interventions

PatupiloneDRUG
Also known as: EPO906
EPO906

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone B

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2008

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

JP(1)