Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC)

Abbvie Deutschland GmbH & Co. KG0 个研究点目标入组 150 人开始时间: 2012年3月21日最近更新: 2015年2月16日

试验速览

暂无简介。

•Subject must be = 18 years of age.
•Life expectancy > 12 weeks (as per Investigator's clinical assessment).
•Subject must have cytologically or histologically confirmed NSCLC.
•Subject must have metastatic or advanced NSCLC (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
•Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1).
•Subject must consent to provide available archived FFPE tissue sample of NSCLC lesion (primary or metastatic) for central review and biomarker analysis.
•Subject must have no history of brain metastases or evidence of primary CNS tumors as demonstrated by a baseline MRI.
•Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
•Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.
•Subject must have adequate bone marrow, renal and hepatic function.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
•Subject has a known hypersensitivity to platinum compounds.
•Subjects with peripheral neuropathy = grade 2.
•Subjects with a known EGFR mutation of exon 19 deletion or L858R mutation in exon 21. (Subjects with wild type EGFR, unknown status or other type of EGFR mutation will be considered eligible).
•Subject has received prior systemic anti-cancer therapy for metastatic NSCLC.
•Subject has received adjuvant chemotherapy = 12 months prior to C1D1.
•Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to C1D1.
•Subject has undergone External Beam Radiation Therapy (EBRT) = 8 weeks prior to C1D1.
•Clinically significant and uncontrolled major medical condition(s).
•Subject has previously been treated with a PARP inhibitor.

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