Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform
NCT ID: NCT00977431
Last Updated: 2019-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-09-17
2017-09-12
Brief Summary
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* radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator) or
* radiotherapy and Temozolomide (in patients with a methylated (silenced) O6-methylguanine-DNA methyltransferase gene (MGMT) to treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen U
BIBW2992 + Radiotherapy
Radiotherapy
Day 1 to day 42
BIBW2992
Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT
Regimen M
BIBW2992 + Temozolomide + Radiotherapy
Temozolomide
During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)
BIBW2992
Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT
Radiotherapy
Day 1 to day 42
Interventions
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Temozolomide
During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)
Radiotherapy
Day 1 to day 42
BIBW2992
Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT
Radiotherapy
Day 1 to day 42
BIBW2992
Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT
Eligibility Criteria
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Inclusion Criteria
2. Proven MGMT gene promoter methylation status
3. Available early postoperative Gd-enhanced MRI (within 72 hours after initial surgery). In case a patient did not perform a Gd-enhanced MRI within 72 hours post surgery, a Gd-MRI is to be performed prior to start of study treatment.
4. Age more or equal to 18 years and less than 70 years at entry
5. Karnofsky Performance Scale (KPS) more or equal to 70%
6. Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of treatment.
7. Written informed consent that is consistent with local law and ICH- Good Clinical Practice (GCP) guidelines.
Exclusion Criteria
2. Planned surgery for other diseases
3. Placement of Gliadel® wafer at surgery.
4. Prior or planned radiotherapy of the cranium including brachytherapy and/or radiosurgery for GBM.
5. Treatment with other investigational drugs; participation in another clinical study including exposure to the investigational product within the past 4 weeks before start of therapy or concomitantly with this study.
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 diarrhoea.
9. Patients with known pre-existing interstitial lung disease
10. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
11. Patient is less than 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.
12. Cardiac left ventricular function with resting ejection fraction less than 50%.
13. Absolute neutrophil count (ANC) less than 1500/mm3.
14. Platelet count less than 100,000/mm3.
15. Bilirubin greater than 1.5 x upper limit of institutional norm.
16. Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
17. Serum creatinine greater than 1.5 x upper limit of institutional norm.
18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
19. Pregnancy or breast-feeding.
20. Patients unable to comply with the protocol.
21. Known or suspected active drug or alcohol abuse.
22. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
18 Years
69 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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Addenbrooke's Hospital
Cambridge, , United Kingdom
Ninewells Hospital & Medical School
Dundee, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Saran F, Welsh L, James A, McBain C, Gattamaneni R, Jefferies S, Harris F, Pemberton K, Schaible J, Bender S, Cseh A, Brada M. Afatinib and radiotherapy, with or without temozolomide, in patients with newly diagnosed glioblastoma: results of a phase I trial. J Neurooncol. 2021 Dec;155(3):307-317. doi: 10.1007/s11060-021-03877-6. Epub 2021 Nov 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2008-007284-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.38
Identifier Type: -
Identifier Source: org_study_id
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