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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Neoplasms

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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