Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02605746
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2015-09-08
Brief Title:
Preoperative Ceritinib LDK378 in Glioblastoma Multiforme and CNS Metastasis
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
A Phase 0II Study of Ceritinib LDK378 in Preoperative Glioblastoma Multiforme GBM and CNS Metastasis Patients Scheduled for Resection to Evaluate Central Nervous System CNS Penetration
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study is being done to learn about a new drug Ceritinib LKD378 The results of the study may reveal how the drug works for cancer that spreads to the brain metastases and for a type of brain cancer called glioblastoma GBM Subjects are persons scheduled to have surgery to remove the tumorThis study would test how much of the new drug is present in the tumor blood and cerebrospinal fluid CSF after taking the drug orally for 10-14 days before surgery It is only given to patients who are already scheduled to have surgery to remove a tumor that has returned If the drug seems to be working for a subjects tumor subject will have the option to continue to receive it as part of a continuation study looking at the drug effect on preventing the tumor from recurring Small samples of blood tumor tissue and CSF will be taken These samples will be sent to and analyzed at the Barbara Ann Karmanos Cancer Institute KCI and to the Translational Genomics Research Institute TGen Subject involvement will be for 10-14 days before surgery and for 30 days following surgery Patients with ALK solid tumors will be provided the option of continuing therapy until tumor progression ALK positivity will be assessed by approved FISH test Abbott Molecular Inc using Vysis break apart probes defined as 15 or more positive tumor cells the Ventana IHC immunohistochemistry test andor NGS next generation sequencing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None