Evaluate the Effects of Patupilone on the Pharmacokinetic... | NCT00448396

Studies
Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

NCT00448396

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 19, 2009Estimated

Enrollment

17Actual

Phase

Phase 1

Conditions

Advanced Malignancies

Interventions

Patupilone

Countries

United States

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

Nov 2009

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

Mar 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Not provided

First Submitted Date

Mar 15, 2007

First Submission Date that Met QC Criteria

Mar 15, 2007

First Posted Date

Mar 16, 2007Estimated

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

Nov 18, 2009

Last Update Posted Date

Nov 19, 2009Estimated

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

17Actual

Label	Type	Description	Intervention Names
Patupilone	Experimental		Drug: Patupilone

Name	Type	Description	Arm Group Labels	Other Names
Patupilone	Drug		Patupilone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies.
Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Age ≥ 18 years of age
Life expectancy ≥3 months
Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study

Exclusion criteria

History of/or active bleeding disorders
Known hypersensitivity to warfarin or related compounds
The use of vitamin K
Central lines that require anticoagulant maintenance
The use of agents containing warfarin and heparin
Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis 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

18 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 Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		San Antonio	Texas		United States

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