EUCTR2020-005651-21-SE进行中（未招募）1 期
A phase I/II, open label, single arm study on safety, tolerability and anti -tumour efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oncorena AB
- 入组人数
- 40
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. Has provided written informed consent.
- •2. Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient.
- •3. For patients in the expansion portion of the study only: Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 2.
- •5. Age >18 years
- •6. Life expectancy >3 months
- •7. Has acceptable haematologic laboratory values defined as:
- •a. Neutrophils =1.5 x 109/L, without growth factor stimulation within 3 weeks prior to the blood test;
- •b. Platelets =100 × 109/L;
- •c. Haemoglobin =5.9 mmol/L (~95 g/L), without transfusion within 4 weeks prior to the blood test. Use of erythropoietin is permitted.
- •8. Must be on chronic haemodialysis (on a consistent regimen for the previous 3 months, with allowance for intermittent treatments as required for volume overload).
- •9. The patient’s treating nephrologist and oncologist agree that the prospect of loss of remaining renal function resulting from this treatment will not significantly change the patients' future and chronic dialysis treatment.
- •10. Female patients of child-bearing potential and male patients must agree to use two highly effective forms of contraception for the duration of study treatment and after the last dose of orellanine for at least 3 months for males and 6 months for females.
- •11. For females of childbearing potential, a negative serum pregnancy test at screening
- •12. Patients who are willing and able to comply with travel requirements, schedule visits, treatment schedule, efficacy assessments, laboratory tests, and other study procedures.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 7 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration).
- •2. Has symptomatic, steroid-dependent, or progressive brain metastasis/metastases. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment.
- •3. Radiotherapy within 4 weeks before first dose.
- •4. Systemic anti-cancer therapy within 4 weeks before first dose.
- •5. Has not recovered from adverse events (AEs) due to prior anti cancer medications to at least grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (except for alopecia and grade 2 neuropathy).
- •6. Has received any other investigational product (IP) within 4 weeks before first dose.
- •7. Pregnant or breastfeeding women.
- •8. Uncontrolled medical condition including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, or would, in the opinion of the investigator, place the patient at increased risk.
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