drugset / Trial / NCT01868022

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

NCT01868022

Phase 1 Completed 65 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2013-10-09
Primary completion
2017-10-24
Completion
2017-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject FP-1039 Unknown 5 mg/kg Intravenous
Subject FP-1039 Unknown 10 mg/kg Intravenous
Subject FP-1039 Unknown 15 mg/kg Intravenous
Subject FP-1039 Unknown 20 mg/kg Intravenous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Docetaxel Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background Pemetrexed Small molecule Intravenous

Indications