EUCTR2006-000236-27-FR进行中（未招募）1 期
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Signed, written informed consent prior to performing any study-related procedures
- •2. Female subjects 18 years of age
- •3. Life expectancy of at least 12 weeks
- •4. ECOG status of 0 or 1.
- •5. Histologically confirmed FIGO Stage IVB, or recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
- •6. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >20 mm when measured by conventional techniques, including palpitation, plain x-ray, CT and MRI, or > 10 mm when measured by spiral CT.
- •7. At least one target lesion” to be used to assess response as defined by Response Evaluation Criteria in Solid Tumors (RECIST; Terasse, 2000). Tumors within a previously irradiated field will be designated as non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- •8. Received 0 or 1 prior chemotherapy regimen for metastatic disease.
- •9. Recovered from the effects of surgery or chemotherapy. At least three weeks must have elapsed from the last administration of chemotherapy.
- •10. Adequate organ and bone marrow function as defined in protocol.
- •11. Ability to swallow and retain oral medication.
- •12. A female is eligible to enter and participate in this study if she meets the criteria outlined in the protocol.
- •13. Must complete all screening assessments as outlined in the protocol.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Neuroendocrine or small cell carcinoma of the cervix.
- •2. Prior use of any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors.
- •3. Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
- •4. Concurrent treatment with an investigational agent or participation in another clinical trial.
- •5. Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
- •6. Has taken or is taking prohibited medications listed in the protocol.
- •7. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient’s safety, obtaining informed consent or compliance to the study.
- •8. History of another malignancy.
- •9. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated.
- •10. Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- •11. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
- •12. Presence of uncontrolled infection.
- •13. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- •14. Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.
- •15. History of any one of the cardiac conditions listed in the protocol within the past 6 months.
- •16. History of cerebrovascular accident or pulmonary embolus within the past 6 months.
- •17. Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (See Appendix 6)
- •18. Poorly controlled hypertension (systolic blood pressure (SBP) of 140mmHg, or diastolic blood pressure (DBP) of 90mmHg).
- •19. History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis).
- •20. Presence of any non-healing, non-tumor related wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
- •21. Subjects with bilateral hydronepherosis which cannot be alleviated by ureteral stents or percutaneous drainage.
- •22. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
- •23. Unable to swallow and retain orally administered medication.
- •24. Pregnant or lactating female.
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