Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis
Status:
Completed
Trial end date:
2019-07-12
Target enrollment:
Participant gender:
Summary
This is two parallel studies to examine pharmacokinetic (PK), pharmacodynamic (PD), and
pharmacogenetic (PG) endpoints following short-interval therapy (10-14) daily doses without
dose reduction and interruption) with the ALK (anaplastic lymphoma kinase) small-molecule
inhibitor, ceritinib.
The Phase 0 study will investigate:
1. first recurrence GBM patients and
2. patients with CNS metastases from solid tumors such as, but not limited to, NSCLC
(non-small cell lung cancer) and melanoma.
The CNS (central nervous system) metastases Phase 0 is designed to identify PK effects (in
addition to PD, and PG effects on ALK-positive NSCLC metastases), while the GBM Phase 0 is
designed to identify PK, PD, and PG effects in all patients.
Phase:
Early Phase 1
Details
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators:
Novartis Translational Genomics Research Institute Wayne State University