BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
NCT ID: NCT00727506
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2008-07-14
2016-05-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIBW 2992
BIBW 2992 once daily
BIBW 2992
BIBW 2992 once daily
TMZ
TMZ 21/28 days
TMZ
TMZ 21/28
BIBW 2992 plus TMZ
BIBW 2992 once daily plus TMZ 21/28 days
BIBW 2992 plus TMZ
BIBW 2992 once daily plus TMZ 21/28 days
Interventions
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BIBW 2992
BIBW 2992 once daily
TMZ
TMZ 21/28
BIBW 2992 plus TMZ
BIBW 2992 once daily plus TMZ 21/28 days
Eligibility Criteria
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Inclusion Criteria
1. Histologically-confirmed WHO Grade III or IV malignant glioma that is recurrent after prior chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade III or IV malignant glioma.
2. Age at least 18 years at entry
3. KPS at least 60%
4. Patients must have recovered from previous surgery and chemotherapy.
5. Written informed consent that is consistent with local law and ICH-GCP guidelines.
Phase II Part:
1. Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade IV malignant glioma and if prior treatment included temozolomide chemotherapy and radiotherapy.
2. Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1).
3. Age at least 18 years at entry
4. KPS at least 70%
5. Patients must have recovered from previous surgery and chemotherapy.
6. Written informed consent that is consistent with local law and ICH-GCP guidelines.
7. Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of study treatment.
Exclusion Criteria
1. Less than 12 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence.
2. Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
3. Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
4. Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
5. Progressive disease or toxicity =CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle).
6. Active infectious disease requiring intravenous therapy.
7. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
8. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
9. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
10. Patient is \<3 years free of another primary malignancy except: if the other primary malignancy is either not currently clinically significant or does not require active intervention (such as a basal cell skin cancer or a cervical carcinoma in situ). Existence of any other malignant disease is not allowed.
11. Cardiac left ventricular function with resting ejection fraction \<50%.
12. Absolute neutrophil count (ANC) less than 1500/mm3.
13. Platelet count less than 100,000/mm3.
14. Bilirubin greater than 1.5 x upper limit of institutional norm.
15. Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
16. Serum creatinine greater than 1.5 x upper limit of institutional norm.
17. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
18. Pregnancy or breast-feeding.
19. Patients unable to comply with the protocol.
20. Known pre-existing interstitial lung disease (ILD).
Phase I part only:
1\. Less than four weeks from prior treatment with bevacizumab.
Phase II Part only:
1. Prior EGFR-directed therapy.
2. Prior bevacizumab therapy.
3. Patients presenting with second or higher number of episodes of recurrence.
4. Requirement of treatment with any of the prohibited concomitant medications listed in Section 4.2.2 (Restrictions regarding concomitant treatment).
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
Québec, Quebec, Canada
Countries
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Other Identifiers
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1200.36
Identifier Type: -
Identifier Source: org_study_id
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