Nimotuzumab in Adults With Glioblastoma Multiforma | NCT00753246

Studies
Nimotuzumab in Adults With Glioblastoma Multiforma

NCT00753246

Sponsor

Oncoscience AG

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Adults With Glioblastoma Multiforma

Interventions

nimotuzumab

Countries

Germany

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 2012

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 2007

Primary Completion Date

Not provided

Completion Date

Jan 2012Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Sep 15, 2008

First Posted Date

Sep 16, 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

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Name	Class
Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany	UNKNOWN
University of Bonn	OTHER
Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Detailed Description

The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm B	Placebo Comparator	adults with TMZ, RT	Drug: nimotuzumab
Arm A	Experimental	adults with TMZ, RT, nimotuzumab	Drug: nimotuzumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nimotuzumab	Drug	monoclonal antibody	Arm A Arm B

Measure	Description	Time Frame
Progression-free interval determined by MRI		week 12, 24, 36, 52

Measure	Description	Time Frame
Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life		week 12, 24, 36, 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient signed informed consent
Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
Condition is measurable by MRI in at least one dimension
Age 18-70
Karnofsky-Index > 40
Treatment in a study center
Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
Adequate haematological, renal and hepatic function:
- Leucocytes >2.0x10^9/l
- Hb> 10g/dl
- Billirubin total < 2.5x upper limit of normal (ULN)
- Creatinin i.S. < 1.5x ULN
- AST (GOT)/ALT (GPT) < 5x ULN

Exclusion Criteria:

Patients with history of anaphylactic reaction to murine or humanized antibody
Patients with evidence second malignancy
Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
Pregnancy and lactation
Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
No MRI for tumour evaluation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided