CTRI/2017/06/008778已完成1 期
Phase I Clinical Trial of an oral therapeutic agent Bioplatin in patients with solid tumours refractory to conventional therapies & advanced metastatic tumours. - NA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histologically-confirmed malignancy that is locally advanced, recurrent or metastatic for which standard curative measures do not exist or are no longer effective.
- •2. Disease that is measurable and/ or evaluable by RECIST criteria5. Patients with prostate cancer require presence of disease on bone scan and/or CT scan and evidence of increasing PSA after standard hormonal therapy
- •3. ECOG Performance6 Status <= 2
- •4. Life expectancy estimated to be at least 3 months
- •5.Acceptable liver function:
- •In the absence of disease involvement in the liver and if bilirubin <= 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and serum alkaline phosphatase may be <= 2.5 times ULN
- •In the presence of disease involvement in the liver and if bilirubin <= 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and serum alkaline phosphatase may be <= 5 times ULN
- •In the presence of bone metastasis, liver specific alkaline phosphatase may be separated from the total and used to assess liver function.
- •6. Acceptable renal function:
- •Serum creatinine <= 1.5 times ULN, OR
- •Calculated creatinine clearance >= 50 mL/min (Cockcroft-Gault formula)
- •7. Acceptable hematologic status:
- •Absolute neutrophil count (ANC) >= 1500 cells/mm3 (1.5 Ã?10e9/L)
- •Platelet count >= 100,000 platelet/mm3 (100 Ã?10e9/L)
- •Hemoglobin >= 9 g/dL
- •Urinalysis with no evidence of proteinuria
- •Acceptable coagulation profile (PT or INR, PTT) < 1.5 times ULN
- •8. Prior Medication: Should not have taken chemotherapy 4 weeks prior to start of clinical trials.
- •9.Patients must give written informed consent before study participation.
- •10.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •1. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •2. Patients participating in another clinical trial of an investigational agent or those who received treatment in another clinical trial within 30 days prior to commencing study treatment.
- •3. Patients with known advanced brain metastases & neurologically compromised are excluded from this clinical trial.
- •4. History of other malignancies except: (1) adequately treated basal cell or squamous cell
- •Carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, c) superficial bladder cancer;
- •5. Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •6. HIV-positive patients and known HBsAg or HCV positive patients.
- •7.Patients receiving any other anti-cancer treatment, aside from control of symptoms
- •8.Underwent major surgery within 28 days prior to commencing study treatment
- •9. History of bleeding diathesis or coagulopathy.
- •10. Refractory nausea or vomiting, malabsorption, dysphagia, significant bowel resection, or
- •any other medical condition that would preclude adequate absorption or result in inability to take oral medication.
- •11. Significant cardiovascular impairment (H/o congestive heart failure NYHA Grade > 2,
- •unstable angina or myocardial infarction within the past 6 months, or serious cardiac
- •arrhythmia)
- •12. Patients with organ allografts requiring immunosuppression.
- •13. Have any medical condition that would interfere with the conduct of the study.
研究者
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