Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04237805
Status:
RECRUITING
Last Update Posted:
2021-07-08
First Post:
2020-01-15
Brief Title:
A Phase III Clinical Study of SAF-189s in Non-small Cell Lung Cancer NSCLC Patients
Sponsor:
Shanghai Fosun Pharmaceutical Industrial Development Co Ltd
Organization:
Shanghai Fosun Pharmaceutical Industrial Development Co Ltd
Study Overview
Official Title:
A Phase III Multi-center Clinical Study Dose-finding Phase I Study of Foritinib Succinate in Advanced ALK-positive NSCLC Patients and Phase II Study of Foritinib Succinate in ALK or ROS1-positive NSCLC Patients
Status:
RECRUITING
Status Verified Date:
2021-05
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 study comprises two phases phase I dose escalation including PK run-in period and treatment period and phase II study
Detailed Description:
This is a multicenter single-arm open-label dose-finding phase III study to determine the MTD and RP2D of oral foritinib succinate monotherapy in patients with advanced ALK-positive malignant solid tumor and to evaluate the safety tolerability and PK characteristics of SAF-189s in patients with advanced ALK-positive NSCLC Phase II clinical study was conducted to evaluate the efficacy tumor activity and safety of remitinib succinate in patients with ALKROS1 positive advanced non-small cell lung cancer and to preliminary evaluate the population pharmacokinetic characteristics of remitinib succinate
This study consisted of two phases phase I including PK induction and continuous administration and phase II Phase I dose escalation the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies Phase I study histologically or cytologically confirmed locally advanced ALK-positive andor metastatic stage IIIBIV NSCLC who have progressed on standard therapy Phase II Study Part I Patients with histologically andor cytologically confirmed ALK or ROS1 positive locally-advanced andor metastatic stage IIIb IV NSCLCPatients who had not previously received or had received only one ALKROS1 inhibitor for disease progression or intolerance and who had no more than 3 previous treatment lines overall Phase II Study Part Ⅱ cohort1ROS1-positive locally advanced andor metastatic stage IIIBIV NSCLC patients diagnosed histologically andor cytologically with no prior systemic therapy or only one line of non-ROS1-inhibitor treatment cohort 2 patients with histologically andor cytologically confirmed ROS1-positive locally advanced andor metastatic stage IIIb IV NSCLC who had previously only received crizotinib as a ROS1 inhibitor for disease progression or intolerance and had no more than 3 overall previous treatment lines
This study consisted of two phases phase I including PK induction and continuous administration and phase II Phase I dose escalation the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies Phase I study histologically or cytologically confirmed locally advanced ALK-positive andor metastatic stage IIIBIV NSCLC who have progressed on standard therapy Phase II Study Part I Patients with histologically andor cytologically confirmed ALK or ROS1 positive locally-advanced andor metastatic stage IIIb IV NSCLCPatients who had not previously received or had received only one ALKROS1 inhibitor for disease progression or intolerance and who had no more than 3 previous treatment lines overall Phase II Study Part Ⅱ cohort1ROS1-positive locally advanced andor metastatic stage IIIBIV NSCLC patients diagnosed histologically andor cytologically with no prior systemic therapy or only one line of non-ROS1-inhibitor treatment cohort 2 patients with histologically andor cytologically confirmed ROS1-positive locally advanced andor metastatic stage IIIb IV NSCLC who had previously only received crizotinib as a ROS1 inhibitor for disease progression or intolerance and had no more than 3 overall previous treatment lines
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