EUCTR2016-002766-31-IT进行中（未招募）1 期
A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first-line or later-line treatment in advanced chordoma. - CHORD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
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
- •- Locally advanced or metastatic, pathologically proven, EGFR expressing chordoma, not amenable for local therapies
- •- Patients of 18 years and up
- •- Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
- •- ECOG Performance status = 2
- •- Adequate bone marrow function (Hb = 6.0 mmol/L, absolute neutrophil count = 1.5 x 109/L, platelets = 75 x 109/L)
- •- An adequate renal function with GFR = 45 ml/min calculated by Cockroft-Gault formula
- •- Total Bilirubin = 1.5 times upper limit of normal (ULN) (Patients with Gilbert’s syndrome total bilirubin must be =4 times institutional upper limit of normal).
- •- Aspartate amino transferase (AST) or alanine amino transferase (ALT) = 3 times ULN (if related to liver metastases = 5 times ULN)
- •- Ability to swallow medication
- •- Recovered from any previous therapy related toxicity to = grade 1 at study entry (except for stable sensory neuropathy = grade 2 and alopecia)
- •- Availability of archival tumor material for central review (if not please obtain a new tumor biopsy)
- •- Written signed informed consent
- •- Ability to adhere to the study visits and all protocol requirements
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •- Life expectancy of less than 3 months
- •- No measurable lesions according to RECIST 1.1
- •- Known hypersensitivity to afatinib
- •- Major surgery less than 4 weeks prior to start of treatment
- •- Previous treatment with any other investigational agents within 14 days of first day of study drug dosing
- •- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of = 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to inclusion.
- •- Known pre-existing interstitial lung disease
- •- Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
- •- Known active hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
- •- Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to an index (or target)lesion within 21 days prior to the first dose of study drug
- •- Requiring treatment with any of the prohibited concomitant medications listed in Section 6.3.9 that cannot be stopped for the duration of trial participation
- •- Pregnant or lactating women
- •- Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer
- •- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
研究者
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