Patupilone (EPO 906) in Patients With Recurrent or Progre... | NCT00715013

Studies
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma

NCT00715013

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 15, 2011Estimated

Enrollment

9Actual

Phase

Phase 1Phase 2

Conditions

Recurrent Glioblastoma Planned for Reoperation

Interventions

Patupilone

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

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

Jul 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 22, 2007

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 14, 2008Estimated

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

Sep 14, 2011

Last Update Posted Date

Sep 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.

Trial with medicinal product

Detailed Description

Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.

The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Name	Type	Description	Arm Group Labels	Other Names
Patupilone	Drug	Patupilone

Measure	Description	Time Frame
Progression free survival		3 years
PFS, OS translational research		3 years

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
> 18 years of age, KPS 70-100%
No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma)
Lc > 3000 und Tc > 100 000, Hb> 9, Bilirubin </= 1.5mg/dl, AST/ALT less than 2.5 x upper limit, creatinine </= 132umol/l
No pregnancy or breast feeding
Written Informed Consent prior to study entry
No reasons for incompliance
Reoperation planned

Exclusion criteria:

KPS < 70%
Radiotherapy- or Chemotherapy within 6 weeks
Enzyme inducing medication or St John's wort
Other study medication within 28 days
Other malignancies
Intolerance of Patupilone
Prior Patupilone
Neuropathy > Grad 1
Other life threatening illnesses
Acute or chronic liver diseases
HIV Infection
Known non-compliance in medication intake,inability to give informed consent
Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris
Active or uncontrolled infection
Pregnancy or breast feeding
Hematologic Growth Factors (without Erythropoetin) colostomy
Patients with uncontrolled diarrhea in the last 7 days prior to study entry.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Feb 7, 2013
Reset	Mar 11, 2013
Release	Jun 6, 2013
Reset	Jul 10, 2013
Release	Oct 14, 2013
Reset	Dec 6, 2013
Release	Apr 4, 2016
Reset	May 6, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 7, 2013			Mar 11, 2013
Jun 6, 2013

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors