Evaluate the Effects of Patupilone on the Pharmacokinetic... | NCT00442741

Studies
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

NCT00442741

Sponsor

Novartis Pharmaceuticals

Status

Withdrawn

Last Update Posted

Apr 25, 2012Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

Patupilone
Patupilone + Omeprazole

Countries

Not provided

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

pts. will be captured in core

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Not provided

First Submitted Date

Mar 1, 2007

First Submission Date that Met QC Criteria

Mar 1, 2007

First Posted Date

Mar 2, 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

Apr 23, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Description Module

Brief Summary

The purpose of this extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.

Detailed Description

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patupilone + Midazolam	Experimental		Drug: Patupilone
Patupilone + Omeprazole	Experimental		Drug: Patupilone + Omeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patupilone	Drug		Patupilone + Midazolam
Patupilone + Omeprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcomes

Measure	Description	Time Frame
Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male or female patients 18 years or older
Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
Completed the Core study
Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters

Exclusion criteria:

Female patients who are pregnant or breast-feeding.
Patients with a severe and/or uncontrolled medical disease
Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
Patients having received an investigational agent within 30 days prior to study entry

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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

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
D009853	Omeprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided