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Brief Title: Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling
Official Title: Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated FGF Pathway Signaling
Study ID: NCT01868022
Brief Summary: This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling. Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line or greater setting of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be enrolled in the study (approximately up to 120 may be enrolled).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, Sacramento, California, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Peoria, Illinois, United States
GSK Investigational Site, Detroit, Michigan, United States
GSK Investigational Site, Saint Louis, Missouri, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Chapel Hill, North Carolina, United States
GSK Investigational Site, Columbus, Ohio, United States
GSK Investigational Site, Charleston, South Carolina, United States
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Koebenhavn Oe, , Denmark
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Arkhangelsk, , Russian Federation
GSK Investigational Site, Ryazan, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, Vsevolozhsk, , Russian Federation
GSK Investigational Site, Badajoz, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Málaga, , Spain
GSK Investigational Site, Sevilla, , Spain
GSK Investigational Site, Leicester, Leicestershire, United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Nottingham, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR