NCT00753246

Brief Summary

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

First QC Date

November 20, 2007

Last Update Submit

November 30, 2012

Conditions

Adults With Glioblastoma Multiforma

Keywords

glioblastoma multiforma

Outcome Measures

Primary Outcomes (1)

  • Progression-free interval determined by MRI

    week 12, 24, 36, 52

Secondary Outcomes (1)

  • 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

Study Arms (2)

Arm B

PLACEBO COMPARATOR

adults with TMZ, RT

Drug: nimotuzumab

Arm A

EXPERIMENTAL

adults with TMZ, RT, nimotuzumab

Drug: nimotuzumab

Interventions

nimotuzumabDRUG

monoclonal antibody

Arm AArm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. Neurosurgery, Univ. Hamburg

Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

nimotuzumab

Study Officials

  • Manfred Westphal, Prof. MD

    University Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2007

First Posted

September 16, 2008

Study Start

August 1, 2007

Study Completion

January 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

DE(1)