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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: Patupilone

• Registration Number: NCT00412789
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Primary Completion: 2008-01
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-28
• Last Update Posted: 2010-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO906	Patupilone	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting Toxicity	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokyo, Japan