Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03130881
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2017-04-19
Brief Title:
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK NSCLC
Sponsor:
Beijing Pearl Biotechnology Limited Liability Company
Organization:
Beijing Pearl Biotechnology Limited Liability Company
Study Overview
Official Title:
A Phase I Open-label Multicenter Dose Escalation Study to Assess the Safety Tolerability and Pharmacokinetics PK of PLB1003 in Patients With ALK-positive ALK Advanced Non-small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
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 phase I first-in-human dose-escalation study was conducted to determine the maximum tolerated dose MTD recommended phase II dose RP2D dose-limiting toxicities DLTs pharmacokinetics PK profile and preliminary antitumor activity of PLB1003
Detailed Description:
This is a Phase I open-label study of PB1003 administered orally to patients with ALK-positive ALK advanced NSCLC The study includes a Dose-escalation Part part A and a Dose Expansion Part part B The aim of the part A is to estimate the MTD and to identify the dose limited toxicityDLT and the recommended phase II dose RP2D for PLB1003 single agent as well as to determine the PKPD profile Once response has been observed in certain dose level then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent Aprox 40 patients will be enrolled in PART A while 12-24 patients for expansion cohort
PLB1003 is a potent selective ALK inhibitor PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer NSCLC tumours
PLB1003 is a potent selective ALK inhibitor PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer NSCLC tumours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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