Status:
COMPLETED
Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Glioblastoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
Brief Summary
This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD), safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor receptor(EGFR)inhibitor) to be ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically-confirmed WHO Grade IV newly diagnosed malignant glioma.
- Proven MGMT gene promoter methylation status
- 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.
- Age more or equal to 18 years and less than 70 years at entry
- Karnofsky Performance Scale (KPS) more or equal to 70%
- Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of treatment.
- Written informed consent that is consistent with local law and ICH- Good Clinical Practice (GCP) guidelines.
- Exclusion criteria:
- Less than two weeks from surgical resection or other major surgical procedure at start of treatment.
- Planned surgery for other diseases
- Placement of Gliadel® wafer at surgery.
- Prior or planned radiotherapy of the cranium including brachytherapy and/or radiosurgery for GBM.
- 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.
- Active infectious disease requiring intravenous therapy.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
- Patients with known pre-existing interstitial lung disease
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
- 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.
- Cardiac left ventricular function with resting ejection fraction less than 50%.
- Absolute neutrophil count (ANC) less than 1500/mm3.
- Platelet count less than 100,000/mm3.
- Bilirubin greater than 1.5 x upper limit of institutional norm.
- Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
- Serum creatinine greater than 1.5 x upper limit of institutional norm.
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
- Pregnancy or breast-feeding.
- Patients unable to comply with the protocol.
- Known or suspected active drug or alcohol abuse.
- Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
Exclusion
Key Trial Info
Start Date :
September 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00977431
Start Date
September 17 2009
End Date
September 12 2017
Last Update
February 18 2019
Active Locations (5)
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1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
2
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
3
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
4
The Christie Hospital
Manchester, United Kingdom, M20 4BX