A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

CompletadoFase 3ClinicalTrials.gov

ID: NCT02264990Tipo: INTERVENTIONALInicio: 30 de sept de 2014Fin estimado: 21 de feb de 2020

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subject must be ≥ 18 years of age with life expectancy \> 12 weeks.
Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Criterios de exclusión

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.
Subject has peripheral neuropathy ≥ grade 2.
Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.

Intervenciones

drug

Paclitaxel

Administered by Intravenous infusion on Day 1 of each 21-day cycle

drug

Carboplatin

Administered by Intravenous infusion on Day 1 of each 21-day cycle

drug

Cisplatin

Administered by Intravenous infusion on Day 1 of each 21-day cycle

drug

Veliparib

Oral capsule, administered twice daily for 7 days in each 21-day cycle

drug

Pemetrexed

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Ubicaciones

Coiba /Id# 132153

Berazategui, Buenos Aires, Argentina

Centro Investigacion Pergamino /ID# 132152

Pergamino, Argentina

Hospital Britanico /ID# 134874

Rosario, Santa FE, Argentina

Instituto de Oncologia de Rosa /ID# 132150

Rosario, Santa FE, Argentina

Patrocinadores

PrincipalAbbVie

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