EUCTR2006-005005-55-GB进行中（未招募）不适用
A Phase I open label trial of continuous dosing with BIBW 2992 combined with paclitaxel and BIBW 2992 combined with paclitaxel and bevacizumab in patients with advanced solid tumours -
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Male
入选标准
- •Histologically confirmed diagnosis of malignancy that is now advanced, non-resectable and / or metastatic.
- •Life expectancy of at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
- •Patients must have recovered from any previous surgery.
- •Adequate organ function
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active infectious disease
- •Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- •GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
- •Significant cardiovascular disease (a history of congestive heart failure requiring therapy, a need for anti-arrhythmic therapy for a ventricular arrhythmia, unstable angina pectoris or myocardial infarction within 6 months prior to trial entry).
- •Patients who require full-dose anticoagulation.
- •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.
- •Patients with untreated or symptomatic brain metastases.
- •Persistent Grade 2 or greater neurotoxicity / neuropathy.
- •Patients on immunosuppressant therapy or with known HIV infection.
- •Treatment with any of the following within 4 weeks of starting trial medication, or during the trial, is not permitted: chemotherapy, immunotherapy, radiotherapy (small field palliative radiotherapy is allowed provided this does not represent clear disease progression), biological therapies (including trastuzumab), hormone therapy (excluding LHRH agonists in prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
- •Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before start of therapy or concomitantly with this trial.
- •Patients with known or suspected hypersensitivity to paclitaxel or compounds similar in composition to BIBW 2992 and their excipients.
- •Patients with known pre-existing interstitial lung disease
- •Additional exclusion criteria for patients recruited to the second stage of the protocol (who will receive bevacizumab):
- •Patients with known or suspected hypersensitivity to bevacizumab, its excipients or Chinese hamster ovary (CHO) cell products or other recombinant human or humanised antibodies.
- •Patients with brain metastases (a brain scan is not required unless the patient shows signs and symptoms of brain metastases and a brain scan is performed to rule out the presence of brain metastases).
- •Patients with intra-abdominal inflammation (risk of gastrointestinal tract perforation in patients with colorectal cancer).
- •Major surgery within 4 weeks of starting treatment or any wound(s) deemed by the investigator to pose a significant risk to the patient in the event of delayed healing.
- •Prior treatment with anthracycline and/or prior radiation to the chest wall may be possible risk factors for the development of congestive heart failure; patients in these categories will only be entered into the study where the investigator deems the benefit to the patient to outweigh the risk.
- •Patients with any of the following conditions (bevacizumab contraindications):
- •significant hypertension
- •significant haemoptysis
- •known brain metastases
- •thrombotic or haemorrhagic disorders
- •INR > 1.5, abnormal PTT
- •therapeutic anti-coagulation
- •squamous non-small cell lung cancer (NSCLC)
研究者
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