A Phase IB Study of GSK3052230 with Chemotherapy in Patients with Metastatic Squamous Cell Lung Cancer or Advanced Pleural Mesothelioma

Protocol
13-256
Full 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
Phase
I
Purpose

Fibroblast growth factor receptor 1 (FGFR1) can cause cancers to grow and divide. FGFs are a group of proteins that turn on FGFR1. GSK3052230 is an investigational drug that traps FGFs and prevents them from turning on FGFR1. Laboratory studies have shown that GSK3052230 can prevent tumors from growing, and that this effect may be greater when the drug is given in combination with chemotherapy.

In this study, researchers want to find the highest dose of GSK3052230 that can be given safely with chemotherapy in patients with squamous cell lung cancers that have spread and have high levels of FGFR1. They will also study the safety of GSK3052230 plus chemotherapy in patients with advanced malignant pleural mesothelioma. Patients will be assigned to one of three groups:

  • GSK3052230 with carboplatin and paclitaxel for patients with untreated stage IV squamous cell lung cancers
  • GSK3052230 with docetaxel for patients with stage IV squamous cell lung cancers that continued to grow despite first-line (initial) treatment
  • GSK3052230 with cisplatin and pemetrexed for patients with untreated advanced malignant pleural mesothelioma

GSK3052230 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have squamous cell cancer of the lung that has spread and contains high levels of FGFR1, or they must have previously untreated advanced malignant pleural mesothelioma.
  • Patients must have recovered from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.

Disease(s)
Lung Cancer, Non-Small Cell: Other
Mesothelioma
Locations
Related Diseases