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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

Estimated reading time: 1 min

Condition

Cancer

Estimated Enrollment: 120

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment

Study ID Numbers: 117360

Study First Received: May 30, 2013

Last Updated: April 7, 2017

Estimated Primary Completion Date: April 14, 2017

Primary Outcome Measures:

Rate and severity of adverse events (AEs) as a measure of safety and tolerability|Number of Participants withdrawn due to AEs as measure of safety and tolerability|Dose interruptions and reduction as a measure of safety and tolerability|Treatment duration as a measure of safety and tolerability|Dose limiting toxicity (DLT) as a measure of safety and tolerability|Change from baseline in vital sign as a measure of safety and tolerability|Change from baseline in 12-lead electrocardiogram (ECG) as a measure of safety and tolerability|Change from baseline in Echocardiogram (ECHO) as measure of safety and tolerability|Change from baseline in laboratory test as measure of safety and tolerability|Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of GSK3052230 in arm A and B|Best response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1|Overall response rate (ORR) per RECIST 1.1 or modified RECIST|Change from baseline in physical examination parameters|Progression-free survival (PFS) by investigator assessment per RECIST 1.1 or modified RECIST|GSK3052230 population pharmacokinetic (PK) profile|Change from baseline in Forced Vital Capacity (FVC) in subjects with MPM

Sponsors and Collaborators:

GlaxoSmithKline

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT01868022

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