BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

Completed · Phase 2

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT00727506

Run by

Boehringer Ingelheim

People needed

151

Starts

2008-07-14

Expected to finish

2016-05-25

Last updated by the study team

2017-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase I Part:
• 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.
• Age at least 18 years at entry
• KPS at least 60%
• Patients must have recovered from previous surgery and chemotherapy.
• Written informed consent that is consistent with local law and ICH-GCP guidelines.
• Phase II Part:
• 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.
• 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).
• Age at least 18 years at entry
• KPS at least 70%
• Patients must have recovered from previous surgery and chemotherapy.
• Written informed consent that is consistent with local law and ICH-GCP guidelines.
• Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of study treatment.

You may not qualify if…

• Phase I and Phase II Parts:
• 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.
• Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
• Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
• Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
• Progressive disease or toxicity =CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle).
• 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 diarrhea.
• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
• 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.
• Cardiac left ventricular function with resting ejection fraction <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 pre-existing interstitial lung disease (ILD).
• Phase I part only:
• Less than four weeks from prior treatment with bevacizumab.
• Phase II Part only:
• Prior EGFR-directed therapy.

Where it is running

• 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

Full record on ClinicalTrials.gov

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