EUCTR2011-002149-36-GB进行中（未招募）1 期
An Open-Label, Single-Arm, Phase 2 Study of G-202 in Patients with Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- Male
入选标准
- •1. Histologically- or cytologically-confirmed prostate adenocarcinoma
- •2. Evidence of radiographic metastatic or recurrent disease. The presence of sclerotic lesions seen on CT scans that are equivocal on the bone will be allowed if the investigator considers these to be metastases
- •3. Chemically- or surgically-castrated patient with documented disease progression as evidenced by one or more of the following three criteria:
- •- Rising PSA, defined according to PCWG2 criteria
- •- Nodal or visceral progression
- •- Evidence of progression of bone metastases
- •4. In patients who have undergone chemical castration, a castrate testosterone level <50 ng/dL within 4 weeks prior to initiation of G-202 treatment and patient agrees to stay on a luteinizing hormone releasing hormone (LHRH) agonist or antagonist medication for the duration of the study
- •5. If on LHRH therapy, must have been on this therapy for at least 3 months prior to study entry
- •6. For any patient previously treated with flutamide (Eulixin®), nilutamide (Nilandron®), or bicalutamide (Casodex®):
- •- Patient treated with flutamide must have discontinued flutamide 4 weeks prior to registration with continued evidence of progressive disease (progressive metastatic or recurrent disease or rising PSA after the discontinuation period)
- •- Patient treated with bicalutamide or nilutamide must have discontinued the drug = 6 weeks prior to registration with evidence of progressive disease (progressive metastatic or recurrent disease or rising PSA after the discontinuation period)
- •7. Absence of known brain metastases (confirmation by CT and/or MRI not required)
- •8. Age =18 years at the time of enrollment
- •9. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •10. Estimated life expectancy of = 6 months
- •11. Adequate hematopoietic function as demonstrated by:
- •- hemoglobin of = 9.0 g/dL without need for sustained blood transfusions
- •- platelet count =100,000 platelet/mm3 (100 x 109/L)
- •- WBC count = 2.0 x109/L and ANC =1.5 x109/L
- •12. Adequate hepatobiliary function as demonstrated by:
- •- Total bilirubin level =1.5 times the upper limit of normal (ULN), unless the patient has Gilbert’s syndrome in which case the patient must have a total bilirubin level = 2.5 x ULN
- •- alanine aminotransferase (ALT) levels = 2.5 x ULN
- •13. Adequate renal function as demonstrated by creatinine level =1.5 x ULN or creatinine clearance (measured or calculated by Cockcroft-Gault formula) = 50mL/min
- •14. Acceptable coagulation profile (PT or INR, PTT < 1.5 x ULN)
- •15. If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of G-202
- •16. Ability to understand and willingness to sign a written informed consent document
- •17. Agree to adhere to the study visit schedule
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Prior chemotherapy for treatment of metastatic or recurrent prostate cancer
- •2. Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists. LHRH agonists or antagonists must have been taken at a steady dose for at least 3 months prior to study entry. The following must be discontinued and cannot be taken within 4 weeks of study entry: 5a-reductase inhibitors (e.g., finasteride, dutasteride), ketoconazole (if given for more than 7 days), aminoglutethimide, megestrol, diethylstilbestrol (DES), abiraterone acetate, MDV3100 (enzalutamide), TAK700, sipuleucel-T. Replacement doses of glucocorticoids are allowed; but chronic daily use of glucocorticoids for prostate cancer is not allowed
- •3. Treatment with therapeutic radionucleotides, such as strontium chloride (Sr89), samarium (Sm153) lexidronam pentasodium, or radium-223 within 12 weeks of study entry
- •4. Radiation therapy < 4 weeks before study entry or not recovered from side effects of prior radiotherapy
- •5. Known brain metastases (CT or MRI not required)
- •6. Documentation of keratosis follicularis, also known as Darier or Darier-White disease.
- •7. Known hypersensitivity to any study drug component, including thapsigargin derivatives, polysorbate 20 or propylene glycol.
- •8. Pre-existing cardiac condition:
- •- Documented myocardial infarction within 6 months of study entry
- •- Pre-existing cardiac failure (NYHA class III-IV)
- •- Atrial fibrillation on anti-coagulants (baby aspirin allowed)
- •- Unstable angina
- •- Severe valvulopathy causing significant symptoms of heart failure (class III-IV)
- •- Cardiac angioplasty or stenting within the last 6 months
- •9. Requirement for use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes as described in Appendix IV.
- •10. Chronic use of moderate or strong opioids for cancer-related pain
- •11. The patient has a QTc value > 470 msec (Appendix V)
- •12. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- •13. Active uncontrolled infection, including known history of AIDS, hepatitis B or C
- •14. Proteinuria level > +2 on urine analysis
- •15. Any psychological condition or geographical situation that could potentially interfere with compliance with the study protocol and follow-up schedule.
- •16. The patient is or is expected to be concurrently receiving any other investigational agents while on study
研究者
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