EUCTR2011-001084-42-HU进行中（未招募）1 期
A Randomized, Phase IIb/III Study of Ganetespib (STA-9090) in Combination with Docetaxel versus Docetaxel alone in Subjects with Stage IIIb or IV Non-Small Cell Lung Cancer
Synta Pharmaceutical Corp.0 个研究点目标入组 385 人开始时间: 2011年5月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 385
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
- All
入选标准
- •1. Male or female subjects aged 18 years or older
- •2. Pathologically confirmed diagnosis of NSCLC
- •3. Stage IIIB or IV NSCLC
- •4. ECOG Performance Status 0 or 1
- •5. Prior therapy defined as:
- •One prior systemic therapy for advanced disease that includes:
- •i. A platinum-based chemotherapy; or
- •ii. EGFR tyrosine kinase inhibitors (TKIs) in EGFR-mutated disease
- •NOTE: Approved maintenance therapy (e.g., pemetrexed) is allowed provided that it was started no more than 4 weeks after the last dose of prior therapy for advanced disease. Prior adjuvant or neoadjuvant therapy for early stage disease is allowed
- •NOTE: Previous anticancer treatment must have stopped at least 2 weeks prior to randomization
- •6. Measurable disease by modified RECIST 1.1
- •7. Radiologic evidence of disease progression following most recent prior treatment.
- •Disease progression is defined as:
- •Appearance of any new lesion or an increase of = 20% of one or more existing lesions. Radiological scans from the subject’s most recent treatment must document the baseline or lowest tumor burden (nadir scans) and disease progression
- •8. Subjects with CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable and the subject has been off steroids after appropriate therapy for at least 3 months prior to randomization
- •9. Adequate hematologic function defined as:
- •Absolute neutrophil count (ANC) = 1.5 × 109/L
- •Hemoglobin = 9 g/dL
- •Platelets = 100 × 109/L
- •10. Adequate hepatic function defined as:
- •Albumin =3 g/dL
- •Serum total bilirubin =1.5 x ULN
- •AST and ALT =1.5 × ULN without liver metastases; =5 × ULN if documented liver metastases
- •11. Adequate renal function defined as
- •Serum Creatinine =1.5 mg/dL or calculated creatinine clearance (CLcr) per Cockgroft- Gault formula = 60mL/min
- •12. Negative serum pregnancy test at study entry for female subjects of childbearing potential
- •13. Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 30 days after the last dose of study drug.
- •14. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •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 444
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 296
排除标准
- •1. Presence of active or untreated CNS metastases as determined by MRI or CT scan performed during screening.
- •2. Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- •3. Serious cardiac illness or medical conditions including but not confined to:
- •History of documented congestive heart failure (CHF), New York Heart Association
- •class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor
- •blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed
- •Baseline QTc > 470 msec or history of QT prolongation while taking other medications
- •Left ventricular ejection fraction (LVEF) < 50 % at baseline
- •High-risk uncontrolled arrhythmias (ventricular tachycardia, high-Grade AV-block, supra-ventricular arrhythmias which are not adequately rate-controlled) that require current treatment with the following anti-arrythmic drugs: flecainide, moricizine or propafenone
- •Current coronary artery disease with a history of myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
- •Radiotherapy within 2 weeks prior to randomization (related toxicities must be =Grade 1)
- •5. Prior radiotherapy to the only area of measurable disease
- •6. Major surgery (unrelated to NSCLC) within 4 weeks prior to randomization
- •7. Hemoptysis = Grade 2 at randomization
- •8. Peripheral neuropathy = Grade 2 at randomization
- •9. History of severe allergic or hypersensitivity reactions to docetaxel or excipients (eg,
- •polyethylene glycol [PEG] 300 and polysorbate 80)
- •10. Women who are pregnant or lactating
- •11. Significant weight loss of = 10% body weight within the 4 weeks prior to randomization
研究者
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