Status:
TERMINATED
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
Lead Sponsor:
Kyowa Kirin Korea Co., Ltd.
Conditions:
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma
Phase 2 Portion : Small Cell Lung Cancer(SCLC)
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01898156
Start Date
July 1 2013
End Date
June 1 2016
Last Update
April 25 2024
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
Seoul, South Korea