PER-112-06已完成未知
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 30 人开始时间: 2007年1月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 0 至 0（—）
入选标准
- •1. Written informed consent signed before performing any procedure related to the study.
- •2. Female patients ≥18 years of age.
- •3. Life expectancy of at least 12 weeks.
- •4. Performance condition according to the Cooperative Group in Eastern Oncology (ECOG) in 0 or 1.
- •5. Cervical cancer histologically confirmed in stage IVB according to FIGO, or squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the recurrent or persistent cervix that is not amenable to a curative treatment with surgery and / or radiation therapy.
- •6. Measurable disease.
- •7. At least one white lesion.
- •8. Not having received any chemotherapy regimen or having received a chemotherapy regimen previously for metastatic disease.
- •9. Having recovered from the effects of surgery or chemotherapy.
- •10. Proper functioning of the organs and bone marrow.
- •11. Ability to swallow and retain medication administered orally.
- •12. A woman is eligible to enter and participate in the present study if: a) She is not able to have family. b) Being able to have a family, has a negative result in a serum test to diagnose pregnancy within 2 weeks prior to receiving the first dose of study medication and agrees to use adequate contraception during their participation in
- •the study; and for a minimum of 2 menstrual cycles after receiving the last dose of study medication.
- •13. Patients must complete all screening evaluations, as outlined in the protocol.
排除标准
- •1. Neuroendocrine carcinoma or carcinoma of the small cell cervix.
- •2. Previous use of some biological therapy with inhibitors of VEGF, VEGFR or ErbB2 / ErbB2 receptors.
- •3. Concurrent therapy against cancer.
- •4. Concurrent treatment with an agent in research or participation in another clinical trial.
- •5. Use of a cancer research drug within 28 days or for 5 half-lives, whichever is longer, before the first dose of study medication is given.
- •6. Have taken or are taking prohibited medications.
- •7. Any other serious and / or unstable medical, psychiatric, or any other condition that could interfere with the patient´s safety.
- •8. History of another malignancy.
- •9. History or clinical evidence of metastasis in the central nervous system or with leptomeningeal carcinomatosis.
- •10. Malabsorption syndrome, a disease that significantly affects gastrointestinal functioning or gastric or small bowel resection.
- •11. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition that increases the risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 4 weeks before starting therapy.
- •12. Presence of an uncontrolled infection.
- •13. Reactions of immediate, delayed hypersensitivity known, or idiosyncratic to drugs chemically related to pazopanib.
- •14. Prolongation of the corrected QT interval (QTc).
- •15. History of any of the following cardiac conditions in the last 6 months: a) Cardiac angioplasty or placement of a cardiac implant (stent). b) Myocardial infarction. c) Unstable angina.
- •16. History of a stroke or pulmonary embolism in the last 6 months.
- •17. With heart failure of functional grades III or IV.
- •18. Poorly controlled hypertension.
- •19. History of deep vein thrombosis (DVT) not treated during the last 6 months.
- •20. Presence of any wound, fracture, or ulcer that does not heal, or the presence of symptomatic peripheral vascular disease.
- •21. Patients with bilateral hydronephrosis that can not be relieved by the placement of ureteral implants (stents) or percutaneous drainage.
- •22. A major surgical procedure, an open biopsy or a significant traumatic injury within 4 weeks prior to initiating therapy, or anticipating the need to undergo a major surgical procedure during the course of the study; It also excludes patients who undergo minor surgical procedures.
- •23. Inability to swallow and retain medication administered orally.
- •24. Pregnant woman or breastfeeding.
研究者
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