Condition
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma|Phase 2 Portion : Small Cell Lung Cancer(SCLC)
Estimated Enrollment: 37
Age Group: 20 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: 8962-002
Study First Received: June 18, 2013
Last Updated: December 13, 2016
Estimated Primary Completion Date: June 2016
Primary Outcome Measures:
Phase 1 – To determine Maximum Tolerated Dose(MTD)|Phase 2 – To assess the objective response rate(Partial Response and Complete Response)|Phase 1 – To evaluate preliminary efficacy|Phase 1 – To determine the q3w pharmacokinetic profile of BIW-8962|Phase 2 – To assess safety and tolerance
Sponsors and Collaborators:
Kyowa Hakko Kirin Korea Co., Ltd.
Website Link: https://ClinicalTrials.gov/show/NCT01898156
