EUCTR2018-000125-30-FR进行中（未招募）1 期
An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of von Hippel-Lindau Disease-Associated Renal Cell Carcinoma - Phase 2 Study of PT2977 for Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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 the ability to understand and willingness to sign a written informed consent form before the performance of any study-specific procedures
- •2. 18 years of age or older
- •3. Has a diagnosis of von Hippel-Lindau disease, based on a germline VHL alteration
- •4. Has at least 1 measurable solid RCC tumor and no RCC tumor greater than 3.0 cm that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Patients may have VHL disease-associated tumors in other organ systems
- •5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •6. Has organ and marrow function as defined below:
- •Absolute neutrophil count = 1,000/µL, hemoglobin level = 10 g/dL and platelet count = 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
- •Serum creatinine level = 2.0 × upper limit of normal (ULN)
- •AST and ALT < 2.5 × ULN, total bilirubin < 1.5 × ULN (< 3 × ULN in patients with Gilbert’s disease), and alkaline phosphatase = 2.5 × ULN
- •7. If a female patient of child bearing potential, or a male patient with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use highly effective methods of contraception during screening, during the period of drug administration and for 90 days after stopping study drug administration. Highly effective contraception methods include the following:
- •Total abstinence,
- •Male or female sterilization, or
- •Use of at least one of the following:
- •a. Use of oral, injected or implanted hormonal methods of contraception
- •b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- •8. Female patients of child-bearing potential must have a negative serum pregnancy test result within 7 days before first administration of study drug
- •9. Able to swallow oral medications
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Has participated in another clinical trial of an investigational drug (or a medical device) within 30 days of study enrollment
- •2. Has received prior treatment with PT2977 or another HIF-2a inhibitor
- •3. Has had any systemic anti-cancer therapy (includes anti-VEGF therapy or any systemic investigational anti-cancer agent)
- •4. Has had radiotherapy within 4 weeks prior to study enrollment
- •5. Has had surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to study enrollment
- •6. Has an immediate need for surgical intervention for tumor treatment
- •7. Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years
- •8. Evidence of metastatic disease on screening imaging.
- •9. Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease
- •10. Has hypersensitivity to the active pharmaceutical ingredient or any component in the formulation
- •11. Has an active infection requiring systemic treatment
- •12. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event, pulmonary embolism, clinically significant ventricular arrhythmias
- •(e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure
- •13. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
- •14. If a female patient, intends to breast feed a child while on study drug or within 30 days after administration of the last dose of study drug
研究者
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