Spots Global Cancer Trial Database for BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
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Trial Identification
Brief Title: BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
Official Title: Phase I/II Trial of BIBW 2992 (Afatinib) in Treating Patients With Recurrent Glioblastoma Multiforme
Study ID: NCT00727506
Conditions
Study Description
Brief Summary: Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV). Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
1200.36.0016 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States
1200.36.0012 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States
1200.36.0005 Boehringer Ingelheim Investigational Site, Duarte, California, United States
1200.36.0014 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
1200.36.0019 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States
1200.36.0023 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
1200.36.0008 Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States
1200.36.0002 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States
1200.36.0003 Boehringer Ingelheim Investigational Site, Detroit, Michigan, United States
1200.36.0009 Boehringer Ingelheim Investigational Site, New York, New York, United States
1200.36.0001 Boehringer Ingelheim Investigational Site, Durham, North Carolina, United States
1200.36.0007 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States
1200.36.0020 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States
1200.36.0017 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States
1200.36.0010 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
1200.36.0011 Boehringer Ingelheim Investigational Site, Charlottesville, Virginia, United States
1200.36.0022 Boehringer Ingelheim Investigational Site, Seattle, Washington, United States
1200.36.1005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada
1200.36.1010 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada
1200.36.1009 Boehringer Ingelheim Investigational Site, Moncton, New Brunswick, Canada
1200.36.1011 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada
1200.36.1008 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada
1200.36.1001 Boehringer Ingelheim Investigational Site, Kingston, Ontario, Canada
1200.36.1003 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
1200.36.1004 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
1200.36.1007 Boehringer Ingelheim Investigational Site, Fleurimont, Quebec, Canada
1200.36.1002 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada
1200.36.1006 Boehringer Ingelheim Investigational Site, Quebec, , Canada
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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