NL-OMON46952招募中不适用
A Phase I, Open label Study to Assess the Safety and Tolerability of KU-0059436 in Combination with Carboplatin and of KU-0059436 in Combination with a Paclitaxel/Carboplatin (TC) doublet and KU-0059436 in combination with Paclitaxel in the Treatment of Patients with Advanced Solid Tumours - Safety,Tolerability of KU-0059436,Carboplatin - Paclitaxel in Solid tumours
Astra Zeneca0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Full informed consent
- •2. Dose escalation phase: male or female patients with a histologically or cytologically diagnosed malignant solid tumour
- •Non-randomised dose expansion phase: female patients with histologically or cytologically diagnosed metastatic triple-negative breast cancer (platinum naive) and female patients with histologically or cytologically diagnosed ovarian cancer, where further treatment with platinum based chemotherapy is indicated.
- •Randomised dose expansion phase: female patients with histologically or cytologically diagnosed measurable metastatic breast cancer and female patients with histologically or cytologically diagnosed measurable ovarian cancer, where further treatment with platinum based chemotherapy is indicated.
- •3. Adequate bone marrow, hepatic and renal function, including the following:
- •a. hemoglobin >= 10.0 g/dl, ANC >= 1500x10 6/l, platelets >= 100.000x10 6/l;
- •b. total bilirubin <= 1,25 x upper normal limit
- •c. AST (SGOT), ALT (SGPT) ,= 2,5 x upper normal limit
- •d. creatinine <= 1,5 x upper normal limit
- •4. Creatinine clearance (Cockcroft-Gault) within normal range (> 60 ml/min)
- •5. Age >= 18 years
- •6. PS <= 2
- •7. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days of start of study.
- •8. The patient is willing to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- •9. Life expectancy of at least 12 weeks.
排除标准
- •1. Any chemotherapy, radiotherapy (except for palliative reasons), endocrine therapy or immunotherpay within 4 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used). Patients may continue the use of biphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study. Heavily pre-treated patients (> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study.
- •Bone marrow deficiency is defined as the occurence of one or other of the events below:
- •- treatment delay in previous chemotherapy courses due to bone marrow toxicity.
- •- previous chemotherapy courses requiring growth factor support.
- •2. Dose escalation phase: more than 2 previous courses of platinum-containing chemotherapy
- •Non-randomised dose expansion phase: more than 2 courses of platinum-containing chemotherapy, except for metastatic triple negative breast cancer patients who must have had no previous platinum-containing chemotherapy.
- •Randomised dose expansion phase: patients where platinum therapy is not indictaed
- •3. Major surgery within 4 weeks of starting the study and patients must have recovered from the effects major surgery.
- •4. Patients with an active second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix. An active second primary cancer is defined as one with a disease free interval of <3 years
- •5. Pre-existing peripheral neuropathy > grade 1.
- •6. Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
- •7. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
- •8. Symptomatic or known brain metastases.
- •9. Gastrointestinal disorders likely to interfere with absorption of the study drug.
- •10. Patients who are unable to swallow oral medication.
- •11. Patients with a history of allergic reactions to carboplatin, platinum containing compounds or mannitol.
- •12. Persistent toxicities (grade 2 or greater) from any cause.
- •13. Pregnant or breast-feeding women.
- •14. Patients with hepatic disease, e.g. patients with known serologically positive Hepatitis B or Hepatitis C as they may be more at risk of toxicity from KU-0059436.
- •15. Immunocompromised patients, e.g. patients who are known to be serologically positive for HIV.
- •16. Treatment with any investigational product during the last 30 days
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