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Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform

Phase I, Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM

NCT00977431•Boehringer Ingelheim

View on ClinicalTrials.gov

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 used in combination with: * 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).

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically-confirmed WHO Grade IV newly diagnosed malignant glioma.
•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

•1. Less than two weeks from surgical resection or other major surgical procedure at start of treatment.
•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.
+12 more criteria

Locations (5)

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

Key Dates

Start Date

September 17, 2009

Primary Completion Date

September 12, 2017

Completion Date

September 12, 2017

Last Updated

February 18, 2019

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Temozolomide

DRUG

Radiotherapy

PROCEDURE

BIBW2992

DRUG

Radiotherapy

PROCEDURE

BIBW2992

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma