Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01625234
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2012-06-15
Brief Title:
Phase 12 Study of X-396 an Oral ALK Inhibitor in Patients With ALK-positive Non-Small Cell Lung Cancer
Sponsor:
Xcovery Holdings Inc
Organization:
Xcovery Holdings Inc
Study Overview
Official Title:
Phase 12 First-in-Human Dose-Escalation Study of X-396 Ensartinib in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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 the first human study to use X-396 ensartinib a drug being developed for treatment of advanced cancers The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans the maximum tolerated dose Once the recommended Phase 2 dose has been determined an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer The study will also provide early information on how the body handles the drug pharmacokinetics and on the efficacy of X-396
Detailed Description:
This is the first study of X-396 ensartinib in humans and the investigational drug will be given as a once or twice daily oral dose in 28 day cycles until there is disease progression or unacceptable safety issues X-396 will be given to small groups of patients 1 - 6 at each dose level and the patients will be observed to see if there are any adverse safety effects As long as there are no unacceptable safety issues after 28 days the dose of X-396 will be increased for the next group of patients This process will continue until the maximum tolerated dose MTD of X-396 is reached Once the MTD is reached up to 170 additional patients will also be given X-396 to further determine the activity of X-396 in patients with ALK-positive non-small cell lung cancer These additional patients will be enrolled in the following expansion cohorts ALK TKI-naïve patients patients that progressed on crizotinib patients that progressed on one or more 2nd generation ALK TKIs patients may or may not have also received prior crizotinib including patients with asymptomatic CNS metastases
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