A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)

Synta Pharmaceuticals Corp0 个研究点目标入组 12 人开始时间: 2012年6月8日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1 Males or females aged 18 years or older
•2 Pathological confirmation (by histology or cytology) of advanced NSCLC
•a. De novo disease (i.e., 0 lines of prior therapy; stage IIIB or IV NSCLC according to the AJCC Cancer Staging Manual 7th Edition 2010
•b. Recurrent disease with up to 3 lines of prior systemic therapy (i.e., 1-3)
•3 Histological confirmation of adenocarcinoma
•4 Evidence of a translocation or an inversion event involving the ALK gene locus as determined by either a local or central laboratory, or prior documentation of ALKpositive status by a local laboratory
•5 Availability of recent tumor tissue or a minimum of 10 slides of archived tumor tissue is required for ALK rearrangement confirmation testing and evaluating relevant biomarkers.
•6 ECOG Performance Status 0 or 1
•7 Adequate hematologic, hepatic and renal function (as defined 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 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Prior therapy with crizotinib
•2. Prior therapy with other ALK-targeted agents
•3. Prior treatment with any Hsp90 inhibitor
•4. Known EGFR activating mutation
•5. Presence of active or untreated central nervous system (CNS) metastases as determined by magnetic resonance imaging (MRI) or computed tomography (CT) scan performed during screening or individuals who have been treated for CNS metastasis and discontinued the steroid treatment less than 4 weeks prior to Cycle 1 Day 1
•6. Active malignancies other than NSCLC within the previous 2 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
•7. Known serious cardiac illness (see protocol for details)
•8. Prior radiotherapy to the only area of measurable disease
•9. Radiotherapy within 2 weeks prior to Cycle 1 Day 1 (related radiotherapy toxicities must be = Grade 1)
•10. Major surgery (unrelated to NSCLC) within 4 weeks prior to Cycle 1 Day 1
•11. Women who are pregnant or lactating
•12. Significant weight loss (=10% body weight) within the 4 weeks prior to Cycle 1 Day 1

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