EUCTR2020-001309-22-DE进行中（未招募）1 期
Evaluation of immunological effects of the hedgehog inhibitors on basal cell carcinoma - An open label, prospective, observational biomarker study of the DeCOG. - ImmunoHedge
IQVIA Commercial GmbH & Co. OHG0 个研究点目标入组 12 人开始时间: 2020年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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. Histologically confirmed diagnosis of advanced BCC (surgery or radiotherapy not possible, contra¬indicated or refused by patient).
- •2. Decision to perform medical treatment with a hedgehog inhibitor with either sonidegib or vismodegib as SoC by an interdisciplinary tumor board. Patients who already received a previous hedgehog inhibitor treatment which was discontinued at least 90 days before start of actual hedgehog inhibitor treatment may also be enrolled.
- •3. Possibility and consent to perform one biopsy of at least 0.5ccm (pea-sized) before initiation of treatment and an additional biopsy 14 days after start of treatment, respectively.
- •4. Age = 18 years.
- •5. Ability to understand and sign a written informed consent.
- •6. Expected survival of at least 6 months.
- •7. ECOG performance status 0, 1 or 2.
- •8. Rest period of at least 2 weeks to prior major surgery, radiotherapy or any previous systemic or local treatment.
- •9. Adequate laboratory parameters including blood count, renal and liver function parameters.
- •- hemoglobin > 9g/L, thrombocytes > 75.000/µL, leukocytes > 2000/µL,
- •- creatinine < 2x upper limit of normal (ULN) or glomerular filtration rate > 30mL/min,
- •- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5x ULN, bilirubin < 3x ULN.
- •10. Adequate contraception according to Pregnancy Prevention Program of the respective hedgehog inhibitor.
- •11. No concomitant use of other approved or investigational antitumor agents.
- •12. No other serious illnesses, in particular hematological neoplasia, which might impact the outcome of the patient or the uptake of the drug significantly.
- •13. Consent to participation in the the prospective skin cancer patients’ registry of Arbeitsgemeinschaft Dermatologische Onkologie (ADOREG) is mandatory for study participation.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Current use of immunosuppressive medication, EXCEPT for the following:
- •- Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection),
- •- Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent,
- •- Steroids as premedication for hypersensitivity reactions (e.g., Computed tomography [CT] scan premedication).
- •2. Active infection requiring systemic therapy.
- •3. Known history of testing positive for Human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •4. Pregnancy or lactation period.
- •5. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
- •6. Known alcohol or drug abuse.
- •7. Legal incapacity or limited legal capacity.
研究者
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