EUCTR2006-000910-19-AT进行中（未招募）不适用
A multi-centre, two-stage, open label phase II study to assess the efficacy and safety of APO866 in the treatment of patients with advanced melanoma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Apoxis SA
- 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
- •To be eligible for inclusion into this study, the subjects must fulfil all of the following
- •Histologically confirmed diagnosis of melanoma
- •Stage IV disease or stage III not amenable to surgery (AJCC, see Appendix A)
- •Measurable disease, defined as at least 1 malignant lesion that could be accurately and serially measured in at least 1 dimension and for which the greatest diameter is > 10 mm as measured by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI), or > 20 mm with conventional techniques. A caliper can be used for the measurement of superficial cutaneous metastases which are > 10 mm.
- •Patients must be able to undergo either contrast-enhanced CT-scan or contrastenhanced MRI scan for tumor assessment
- •Only one previous systemic treatment (excluding prior systemic treatment as
- •postoperative adjuvant therapy) is allowed and should have been terminated > 4
- •weeks before Study Day 1 (SD1).
- •Lack of response or progression of disease after the most recent systemic therapy for advanced melanoma
- •Patients must have recovered from the toxicity of any previously used treatment.
- •All Adverse events of previous systemic treatment must have resolved to < grade I Common Terminology Criteria for Adverse Events
- •ECOG Performance Status < 1
- •Age > 18 years, of either sex
- •Female patients with childbearing potential must be using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with
- •spermicide for the duration of the study. Women of childbearing potential must have a negative serum or urinary hCG pregnancy test within 7 days prior to Study Day 1
- •Male patients, who are not surgically sterile, must use a condom with spermicide
- •for the duration of the study and 3 months thereafter
- •Have given written informed consent, prior to any study related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •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
- •To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- •Have participated in any other investigational study or received an experimental
- •therapeutic procedure considered to interfere with the study in the 4 weeks preceding SD1
- •History of brain metastases or leptomeningeal disease
- •Bone-only metastatic disease
- •Use of prohibited medication due to CYP3A4 metabolism of APO866, as specified in Section 6.6.2. concomitant use of these drugs will not be allowed during the study.
- •Uncontrolled medical conditions, requiring surgical or pharmacological treatment (exceptions must be approved by the Medical Responsible of the study).
- •Serious concomitant disease (e.g. significant cardiac disease)
- •History of second cancer that was treated with curative intent and in complete
- •remission for < 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
- •Primary or acquired thrombocytopenia
- •Inadequate bone marrow reserve: WBC < 3.5x109/L, neutrophils < 1.0x109/L,
- •thrombocytes < 100x109/L, Hb < 10.0 g/dL or coagulation abnormalities
- •Inadequate liver function: total bilirubin > 1.5 x upper limit of normal values
- •(ULN), AST, ALT, or alkaline phosphatase > 2.5 x ULN
- •Have inadequate renal function, defined by serum creatinine > 1.5x ULN
- •Retinopathy, history of retinal laser surgery, or an ERG < 50% of normal
- •Pregnant of lactating female
- •Abuse of alcohol or other recreational drugs
研究者
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