EUCTR2006-000236-27-IT进行中（未招募）不适用
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 for Advanced/Recurrent Disease
GlaxoSmithKline R&D Ltd0 个研究点目标入组 180 人开始时间: 2007年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- 性别
- Female
入选标准
- •1. Signed, written informed consent prior to performing any study-related procedures 2. Female subjects major or equal to 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. ? Note: Chemotherapy given in combination with radiation therapy as a radiosensitizer does not count toward this prior therapy limit 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 Table 2. 11. Ability to swallow and retain oral medication. 12. A female is eligible to enter and participate in this study if she is of: ? Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: o A hysterectomy o A bilateral oophorectomy (ovariectomy) o A bilateral tubal ligation o Is post-menopausal (total cessation of menses for at least 1 year) ? Childbearing potential, has a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: o An intrauterine device with a documented failure rate of less than 1% per year. o Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female. o Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 21 days after the last dose of investigational product. o Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). Note: Oral contraceptives are not reliable due to potential drug-drug interaction. 13. Must complete all screening assessments as outlined in the protocol. Note: Subjects must provide written informed consent prior to performance of any study-specific procedures or assessments (including initial diagnosis) and are willing to comply with treatment and follow-up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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) no
- •F.1.3.1 Number of subjects for this
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. Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. 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.
研究者
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