PER-078-05已完成未知
DOUBLE-BLIND, RANDOMIZED, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL GROUPS AND DOSAGE RANGE STUDIES TO EVALUATE THE EFFECTIVENESS, SAFETY AND PHARMACOKINETICS OF AN ORAL AGONISTER OF THE TROMBOPOIETIN RECEIVER (SB-497115-GR) ADMINISTERED AT DOSES OF 50, 75 AND 100 MG TO PATIENTS WITH CANCER WHO RECEIVE MULTIPLE CYCLES OF CHEMOTHERAPY
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2006年1月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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. Patients> 18 years of age, without previous chemotherapy treatment, with advanced solid tumor with histological or cytological confirmation.
- •2. Patients who will receive first-line chemotherapy with carboplatin ABC 5-6 EV in 30 minutes plus paclitaxel 175-225 mg / m2 EV in three hours on day 1 every 21 days.
- •3. Functional State ECOG-Zubrod 0 or 1.
- •4. The patient has no history of platelet alterations and has no history of hemorrhagic diseases.
- •5. Patients have an adequate: Hematological function, liver function, renal function.
排除标准
- •1. Any clinically relevant abnormality, in addition to cancer or any other medical condition or circumstance that makes the subject unfit to participate in the study and / or which could hinder the interpretation of the patient´s data.
- •2. Patient with a known history of accelerated progressive disease, surgery within 2 weeks prior, radiotherapy within the previous 4 weeks or any previous chemotherapy.
- •3. Patients with known prior heart disease.
- •4. Patients with abnormal 12-lead ECG.
- •5. Patients with known coagulation diseases that are associated with hypercoagulability.
- •6. The patient consumed aspirin, compounds containing aspirin, salicylates, quinine or nonsteroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days within 2 weeks of the start of the study and could require them at any time during the study.
- •7. Treatment with an investigational drug within 30 days or 5 half-lives before the study.
- •8. The patient consumed liquid antacids, chewable antacids or calcium supplements within 48 hours of the first dose of the study medication.
- •9. The patient consumed rosuvastatin or pravastatin within one week of the first dose of study medication.
- •10. Any history of drug-induced thrombocytopenia.
- •11. Use of systemic anticoagulants within 4 weeks prior to entry into the study.
- •12. Consumption of any phytotherapeutic supplement or dietary supplements, within 1 week of the beginning of the study.
- •13. Female patients who are breastfeeding or have a beta-hCG positive test in the screening study.
- •14. Patients with a history of CNS metastasis or signs or clinical symptoms of brain and / or leptomeningeal metastases with CT confirmation or brain MRI examination.
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