EUCTR2009-010571-24-GB进行中（未招募）1 期
An open label, multicenter, Phase I/II study of pazopanib in combination with paclitaxel in first line treatment of subjects with stage IIIBwet/IV non-small cell lung cancer
适应症
相关药物
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
- •Specific information regarding warnings, precautions, contraindications, AEs, and other pertinent information on the IP that may impact subject eligibility is provided in the IB for pazopanib. For paclitaxel and carboplatin, please refer to the approved product labels.
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •Must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments. Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be used for screening or baseline purposes provided these procedures were conducted as specified in the protocol.
- •Age 18 years old or greater (or legal age of consent if greater than 18 years)
- •Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC. Phase I only: Additionally, subjects with histologically- or cytologically-confirmed diagnosis of advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy may also be entered.
- •ECOG performance status of 0 or 1 (Appendix 3).
- •Life expectancy of at least 12 weeks.
- •Measurable disease as defined by RECIST criteria (Section 6.2.3) [Therasse, 2000]
- •No prior systemic first-line therapy for Stage IIIBwet/IV NSCLC either by chemotherapy or any other systemic treatment. Prior surgery and/or localised irradiation for NSCLC are permitted as long as it was a minimum of 4 weeks before entering the study. Subjects with recurrence after previous NSCLC that has been treated with surgery and adjuvant chemotherapy or a radio-chemotherapy regimen with curative intent are eligible, provided 1 year has passed since this treatment ended. Phase I only: No prior systemic first-line therapy for treatment of the advanced solid tumor.
- •Able to swallow and retain oral medication.
- •Adequate organ system function as defined in Table 3.
- •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:
- •A hysterectomy
- •A bilateral oophorectomy (ovariectomy)
- •A bilateral tubal ligation
- •Or who is post-menopausal
- •Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for =1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L). For most forms of HRT, at least 2 to 4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female subject is determined not to be post-menopausal, she must use adequate contraception, as defined immediately below.
- •Childbearing potential, including any female who has had a negative serum pregnancy test within one week prior to the first dose of study treatment, preferably as close to the first dose as possible and
排除标准
- •Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC. Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. Phase I only: subjects with advanced solid tumors are eligible for the study; only one active malignancy is permitted.
- •History or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 1 week prior to first dose of study drug. Screening with CNS imaging (computerised tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- •Clinically significant gastrointestinal abnormalities including, but not limited to:
- •Malabsorption syndrome .
- •Major resection of the stomach or small bowel that could affect the absorption of study drug.
- •Active peptic ulcer disease.
- •Known intraluminal metastatic lesion/s with risk of bleeding.
- •Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation.
- •History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- •Presence of uncontrolled infection.
- •Prolongation of heart-rate corrected QT interval (QTc) >480 msecs (using Bazett’s formula).
- •History of at least one of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting.
- •Myocardial infarction.
- •Unstable angina.
- •Symptomatic peripheral vascular disease.
- •Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA; Appendix 4).
- •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of =90 mmHg].
- •Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (See Section 6.3.3 for details on BP control and re-assessment prior to study enrollment).
- •8. History of cerebrovascular accident, including transient ischemic attack (TIA), PE, or untreated DVT within the past 6 months.
- •Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
- •9. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- •10. Evidence of active bleeding or bleeding diathesis.
- •11. Recent haemoptysis (½ teaspoon of red blood within 8 weeks before first dose of study drug).
- •12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels (Note: tumour abutting the vessels is a
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