EUCTR2008-006288-36-GB进行中（未招募）不适用
Phase II open label trial to assess the efficacy and the impact on QTcF of continuous oral BIBW 2992 at a daily dose of 50 mg in patients with relapsed or refractory solid tumours including patients with brain metastases and those with glioblastoma not amenable to other therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients aged at least 18 years old.
- •2. Histologically or cytologically confirmed diagnosis of a solid malignant tumour, known to historically express EGFR/HER2 that is either refractory to standard therapies, or for which no standard treatment is available (including patients with brain metastases).
- •3. At least one tumor lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as =20 mm using conventional techniques or or =10 mm with spiral CT scan.
- •4. Life expectancy of at least 3 months.
- •5. Written informed consent that is consistent with ICH-GCP guidelines.
- •6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0,1 or 2.
- •7. Patients must have recovered from any previous surgery.
- •8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment. Breast feeding mothers will be excluded since these agents may be toxic to infants.
- •For patients with Glioma and brain metastases the following additional inclusion criteria should apply:
- •1. Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemo-radiotherapy. Patients with prior low-grade glioma are eligible if histological assessment demonstrates transformation to WHO Grade IV malignant glioma.
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Active infectious disease
- •2. Patients unable to comply with the protocol.
- •3. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g., Crohn’s disease, malabsorption, or CTCAE Grade >2 diarrhoea of any aetiology at baseline.
- •4. Patients who have any other life-threatening illness or organ system dysfunction which, in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- •5. Other malignancies diagnosed within the past five (5) years (other than non
- •melanomatous skin cancer and in situ cervical cancer).
- •6. Patients with any serious active infection (i.e., requiring an i.v. antibiotic, antifungal, or antiviral agents).
- •7. Patients with known HIV, active hepatitis B or active hepatitis C infection
- •8. Known or suspected active drug or alcohol abuse.
- •9. Radiotherapy within the past 2 weeks prior to treatment with the trial drug.
- •10. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration
- •11. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC < Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
- •12. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2
- •inhibiting drugs within the four weeks prior to start of therapy or concomitantly with thistrial.
- •13. Pregnancy or breast feeding.
- •14. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial.
- •15. History of clinically significant or uncontrolled cardiac disease, including congestive
- •heart failure, angina, myocardial infarction, arrhythmia, including New York Heart
- •Association (NYHA) functional classification of 3.
- •16. Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
- •17. QTcF- interval > 470 ms at screening
- •18. PR-interval > 230 ms at screening
- •19. QRS-interval >120 ms at screening
- •20. ST-segment and T/U-wave abnormalities at screening, as will be assessed by a cardiology specialist of a central lab ( Nabios GmbH)
- •21. Absolute neutrophil count (ANC) less than 1,500/mm3.
- •22. Platelet count less than 100,000 / mm3.
- •23. Bilirubin greater than 1.5 mg / dl (>26 µmol / L, SI unit equivalent). Aspartate amino transferase (AST) or alanine amino transferase (ALT) > than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal).
- •24. Serum creatinine greater than 1.5 times of the upper normal limit or calculated/measured creatinine clearance = 45 ml / min.
- •25. Patients with known Interstitial Lung Disease (ILD)
- •For Patients with glioma and brain metastases additional exclusion criteria apply
- •1. Patients with untreated or symptomatic brain metastases. Patients with treated,
- •asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks. Steroids will be allowed. Anti-epileptic therapy will be allowed
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