NL-OMON54671已完成2 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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, with interval between 2 pre-treatment scans of <= 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 review (if
- •not please obtain a new tumor biopsy), - Written signed informed consent, -
- •Ability to adhere to the study visits and all protocol requirements
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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