Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01742286
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2012-11-30
Brief Title:
Phase I Study of LDK378 in Pediatric Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase ALK
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I Open-label Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase ALK
Status:
COMPLETED
Status Verified Date:
2020-05
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:
The purpose of this study was to estimate the maximum tolerated dose andor recommended dose for expansion of LDK378 as a single agent assess safety tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors with and without food
Detailed Description:
LDK378 is a novel inhibitor of ALK that is active in a broad range of ALK-activated tumor models including models driven by mutated versions of ALK known to be resistant to crizotinib and by ALK gene amplification
The primary purpose of this study was to determine the maximum tolerated dose andor recommended dose for expansion in pediatric patients and to delineate a clinical dose to be used in any future pediatric studies with and without food This study also assessed the safety tolerability PK and preliminary evidence of antitumor activity of LDK378 in pediatric patients with neuroblastoma and other ALK-activated tumors
Fasted cohort each daily dose of LDK378 including days which involved PK blood sampling was taken at least 2 hours after last meal subjects did not eat until 1 hour after LDK378 was taken Each daily dose of LDK378 was taken with 1-2 tablespoons 15-30 mL of an appropriate food such as applesauce or non-fat yogurt a glass of water
Fed cohort each daily dose of LDK378 including days which involved PK blood sampling was taken with or within 30 minutes after finishing a low-fat light snack containing 100-300 calories 15-2 grams of fat
The primary purpose of this study was to determine the maximum tolerated dose andor recommended dose for expansion in pediatric patients and to delineate a clinical dose to be used in any future pediatric studies with and without food This study also assessed the safety tolerability PK and preliminary evidence of antitumor activity of LDK378 in pediatric patients with neuroblastoma and other ALK-activated tumors
Fasted cohort each daily dose of LDK378 including days which involved PK blood sampling was taken at least 2 hours after last meal subjects did not eat until 1 hour after LDK378 was taken Each daily dose of LDK378 was taken with 1-2 tablespoons 15-30 mL of an appropriate food such as applesauce or non-fat yogurt a glass of water
Fed cohort each daily dose of LDK378 including days which involved PK blood sampling was taken with or within 30 minutes after finishing a low-fat light snack containing 100-300 calories 15-2 grams of fat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-002074-31 | EUDRACT_NUMBER | None | None |