Efficacy and Safety of Patupilone in Patients With Advanc... | NCT00412789

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

NCT00412789

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

May 31, 2010Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Tumors

Interventions

Patupilone

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Not provided

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2010

Last Update Posted Date

May 31, 2010Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
EPO906	Experimental		Drug: Patupilone

Name	Type	Description	Arm Group Labels	Other Names
Patupilone	Drug		EPO906	EPO906

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose-limiting Toxicity		18 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093788	epothilone B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided