Nüks Eden Habis Gliom Tedavisinde BIBW 2992 (Afatinib) ile Günlük Temozolomidin Birlikte veya Ayrı Kullanımı

Sade dilde özet

Bu çalışma, önceki tedavi sonrası nüks eden habis beyin tümörü gliom (malignant glioma) hastalarında BIBW 2992 (Afatinib) ilacını, Temozolomid eklenerek veya eklenmeden inceliyor. WHO Derece III veya IV gliom tanılı, 18 yaş üstü hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Boehringer Ingelheim

Müdahale

BIBW 2992, TMZ, BIBW 2992 plus TMZ

Başlangıç

14.07.2008

Tahmini bitiş

25.05.2016

Ülkeler

United States, Canada

İlgili genler

Merkezler

• Birmingham, United States
• Phoenix, United States
• Duarte, United States
• Los Angeles, United States
• Orlando, United States
• Atlanta, United States
• Louisville, United States
• Boston, United States
• Detroit, United States
• New York, United States
• Durham, United States
• Charleston, United States
• Memphis, United States
• Dallas, United States
• Houston, United States
• Charlottesville, United States
• Seattle, United States
• Calgary, Canada
• Winnipeg, Canada
• Moncton, Canada
• Halifax, Canada
• Hamilton, Canada
• Kingston, Canada
• Toronto, Canada
• Toronto, Canada
• Fleurimont, Canada
• Montreal, Canada
• Québec, Canada

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion criteria:

Phase I Part:

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:

Phase I and Phase II Parts:

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).