Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With L… (NCT01898156) | Clinical Trial Compass
TerminatedPhase 1/2
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
Stopped: lack of efficacy
South Korea37 participantsStarted 2013-07
Plain-language summary
This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
* Phase 2: measurable, unresectable advanced or recurrent SCLC
* A life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
* Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
* Adequate hematologic, hepatic, renal and lung function
Exclusion Criteria:
* Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
* Subject received monoclonal antibodies within 4 weeks of the first dose
* Major surgery within 4 weeks prior to the first dose
* Known symptomatic brain metastases
* Clinically significant cardiovascular disease
* Leptomeningeal disease
* Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
* Known HIV disease or acquired immunodeficiency syndrome-related illness
* A psychiatric illness, disability or social situation
* Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
* A history of primary brain/CNS malignancy
* Neurological paraneoplastic syndrome
What they're measuring
1
Phase 1 - To determine Maximum Tolerated Dose(MTD)
Timeframe: First 3-week cycle of treatment
2
Phase 2 - To assess the objective response rate(Partial Response and Complete Response)
Timeframe: Until Progressive Disease (PD) determined