NL-OMON41451已完成3 期
A Randomized Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma - 9090-14 (Galaxy-2)
Synta Pharmaceuticals Corporation0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
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
- 18 至 99（—）
入选标准
- •A patient is eligible for the study if all of the following criteria are met:
- •1. Age 18 years or older
- •2. Pathologically confirmed diagnosis of NSCLC, with predominantly adenocarcinoma histology. Tumors must be negative for both EGFR mutations and ALK translocations.
- •3. Stage IIIB/IV NSCLC
- •4. Only one prior systemic therapy for Stage IIIB/IV disease defined as a platinum-based combination chemotherapy
- •5. Diagnosis of advanced NSCLC *6 months prior to signing of informed consent document
- •6. Documented disease progression during or following first-line therapy for advanced disease
- •7. Measurable disease
- •8. Available archived tumor tissue block with sufficient tumor tissue for biomarker testing; alternatively unstained slides with sufficient tumor tissue may be substituted. If archived tissue is not available, a fresh biopsy will be obtained during the screening period.
- •9. ECOG PS 0 or 1
- •10. Adequate hematologic function defined as:
- •* Absolute neutrophil count (ANC) *1.5 × 10(9)/L
- •* Hemoglobin *9 g/dL
- •11. Platelets *100 × 10(9)/L Adequate hepatic function defined as:
- •* Albumin *3 g/dL
- •* Serum total bilirubin *1.5 x ULN
- •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- •*1.5 × ULN without liver metastases; *5 × ULN if documented liver metastases
- •12. Adequate renal function defined as:
- •* Serum creatinine *1.5 x ULN or calculated creatinine clearance (cCrCl) per Cockcroft-Gault formula * 50mL/min
- •13. Negative serum human chorionic gonadotropin pregnancy test at study entry for patients of childbearing potential. Patients of reproductive potential must agree to use adequate contraception for the duration of study treatment and for 30 days after the last dose of
- •ganetespib, and for 3 months (women) and 6 months (men) after the last dose of docetaxel since docetaxel can have genotoxic effects and may alter male fertility.
- •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.
排除标准
- •1. Predominantly squamous, adenosquamous histology, or unclear histologic type
- •2. Prior maintenance therapy with an investigational anticancer agent
- •3. Prior treatment with tyrosine kinase inhibitors (TKIs) for lung cancer.
- •4. Patients with tumors known to harbor molecular alterations for which a targeted therapy is approved.
- •NOTE: Patients whose tumors have not been tested for molecular alterations for which a targeted therapy is approved are not eligible.
- •5. Presence or suspicion of central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis as determined by magnetic resonance imaging/computed tomography (MRI/CT) scan performed at screening.
- •NOTE: Patients who have stable CNS metastases for at least 2 weeks following completion of radiotherapy are eligible
- •6. Active malignancies other than NSCLC within the last 5 years except for adequately treated in situ carcinoma of the cervix uteri, or basal or squamous cell carcinoma of the skin
- •7. Significant weight loss defined as *10% body weight within the 4 weeks prior to randomization
- •8. History of pulmonary hemorrhage or hemoptysis National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) *Grade 2 within 4 months of randomization
- •9. Peripheral neuropathy NCI CTCAE *Grade 2 at baseline
- •10. Patients with only 1 measurable lesion that was exposed to prior radiotherapy; the exception is lesions with documented disease progression with new tissue growth of at least 1 cm in longest diameter compared to nadir scan.
- •NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of study drug
- •11. Known serious cardiac illness or medical conditions, including but not limited to:
- •i. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
- •ii. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic drug (eg, sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
- •iii. Use of medications that have been linked to the occurrence of torsades de pointes
- •iv. Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker
- •v. Complete left bundle branch block (LBBB)
- •vi. History of long QT Syndrome or a family member with this condition
- •vii. QTc >470 ms (average of triplicate ECG recordings). A consistent method of QTc calculation must be used for each patient's QTc measurements. QTcF (Fridericia's formula) is preferred.
- •viii. Serum potassium, magnesium, or calcium levels outside the laboratory's reference range
- •12. Uncontrolled intercurrent illness including, but not limited to, patients receiving combination antiretroviral therapy or patients with severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •13. Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient
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