Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM) - Estimated End January 2013
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Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM) - Estimated End January 2013

  • Saturday, 22 January 2011 08:06

This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, December 2010
First Received: July 28, 2009   Last Updated: January 6, 2011   History of Changes
Sponsor: Bristol-Myers Squibb
Collaborator: European Organization for Research and Treatment of Cancer
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00948389
Purpose

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma


Condition Intervention Phase
Glioblastoma
Drug: Dasatinib
Drug: Lomustine
Phase I
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary outcome measure for the safety cohort portion is that hematological and non-hematological toxicity [ Time Frame: The primary outcome measure for the safety cohort portion is assessed every 2 weeks during the first 2 treatment cycles for the first 3 patients and every 2 weeks during the first treatment cycle for the next 7 patients ] [ Designated as safety issue: Yes ]
  • The primary outcome measure for the phase II portion is the proportion of subjects free of disease progression measured by brain MRI [ Time Frame: The primary outcome measure for the phase II portion is assessed every 6 weeks until 6 months after start of study treatment administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective responses and Progression-free survival distribution [ Time Frame: assessed every 6 weeks until study treatment discontinuation ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: assessed at 12 months, at 24 months and at the end of the study ] [ Designated as safety issue: No ]
  • Toxicity profile (% of worst AEs and laboratory event grades) [ Time Frame: assessed every 2 weeks until study treatment discontinuation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: October 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dasatinib: Active Comparator
Intervention: Drug: Dasatinib
Drug: Dasatinib
Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity
Other Name: BMS-354825
Lomustine: Active Comparator
Intervention: Drug: Lomustine
Drug: Lomustine
Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Patients with histological or cytological proven Glioblastoma Multiforme
  • Recurrent or progressive disease documented by MRI
  • WHO Performance status 0 - 2
  • Patient may have been operated for recurrence
  • For non operated patients, recurrent disease must be at least one bidimensionally measurable target Lesion with one diameter of at least 2cm
  • Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI

Exclusion Criteria:

  • Patients with histological or cytological proven glioblastoma multiforme
  • Completion of Radiotherapy to the brain less than 3 months prior to registration/randomization
  • Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy
  • Previous or current malignancy at other sites within prior 3 years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948389

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
Belgium
Local Institution Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Site 022
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 017
France
Local Institution Not yet recruiting
Bordeaux, France, 33076
Contact: Site 025
Local Institution Not yet recruiting
Lyon Cedex 03, France, 69394
Contact: Site 013
Local Institution Not yet recruiting
Marseille Cedex 05, France, 13385
Contact: Site 012
Local Institution Not yet recruiting
Nancy, France, 54035
Contact: Site 024
Local Institution Recruiting
Paris Cedex, France, 75013
Contact: Site 011
Germany
Local Institution Not yet recruiting
Bochum, Germany, 44892
Contact: Site 010
Local Institution Not yet recruiting
Bonn, Germany, 53105
Contact: Site 003
Local Institution Not yet recruiting
Frankfurt Am Main, Germany, 60528
Contact: Site 002
Local Institution Not yet recruiting
Heidelberg, Germany, 69120
Contact: Site 026
Israel
Local Institution Not yet recruiting
Haifa, Israel, 31096
Contact: Site 007
Italy
Local Institution Recruiting
Bologna, Italy, 40139
Contact: Site 001
Local Institution Not yet recruiting
Milano, Italy, 20127
Contact: Site 008
Netherlands
Local Institution Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Site 019
Local Institution Recruiting
Rotterdam, Netherlands, 3075 EA
Contact: Site 015
Switzerland
Local Institution Not yet recruiting
Geneva, Switzerland, 1211
Contact: Site 009
Local Institution Recruiting
Lausanne, Switzerland, 1011
Contact: Site 005
Local Institution Not yet recruiting
Zuerich, Switzerland, 8091
Contact: Site 006
United Kingdom
Local Institution Not yet recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 018
Local Institution Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 028
Local Institution Not yet recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Contact: Site 027
Local Institution Not yet recruiting
Glasgow, Strathclyde, United Kingdom, G12 0YN
Contact: Site 023
Local Institution Not yet recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Contact: Site 020
Local Institution Not yet recruiting
Wirral, United Kingdom, L63 3LY
Contact: Site 014
Sponsors and Collaborators
Bristol-Myers Squibb
European Organization for Research and Treatment of Cancer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
ClinicalTrials.gov Identifier: NCT00948389 History of Changes
Other Study ID Numbers: CA180-274, EORTC protocol 26083, Eudract# 2009-010576-21
Study First Received: July 28, 2009
Last Updated: January 6, 2011
Health Authority: European Union: European Medicines Agency;   Belgium: Federal Agency for Medicinal Products and Health Products;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Israel: Israeli Health Ministry Pharmaceutical Administration;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Switzerland: Swissmedic;   United Kingdom: Medicines and Healthcare Products Regulatory Agency
 


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