Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632574
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Study Evaluating the Safety Tolerability and Pharmacokinetic Characteristics of Paclitaxel Cationic Liposome for Injection in the Treatment of Patients With Advanced Solid Tumors Via Transcatheter Arterial Infusion Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label dose-escalation and expansion cohort expansion multicenter Phase I clinical study in patients with advanced solid tumors
Detailed Description:
This is an open-label dose-escalation and expansion cohort expansion multicenter Phase I clinical study in patients with advanced solid tumors
The study aims to evaluate the safety tolerability pharmacokinetic characteristics and preliminary efficacy of paclitaxel cationic liposomes for injection administered via transcatheter arterial infusion in the treatment of advanced solid tumors
Paclitaxel cationic liposomes will be administered via arterial infusion on the first day of each cycle with each treatment cycle lasting 3 weeks Eligible participants will receive 4-6 cycles of study treatment Treatment may be terminated early in the event of the following disease progression intolerable toxicity initiation of new anti-tumor therapy withdrawal of informed consent loss to follow-up death or any other circumstances meeting the criteria for treatment discontinuation whichever occurs first
The study aims to evaluate the safety tolerability pharmacokinetic characteristics and preliminary efficacy of paclitaxel cationic liposomes for injection administered via transcatheter arterial infusion in the treatment of advanced solid tumors
Paclitaxel cationic liposomes will be administered via arterial infusion on the first day of each cycle with each treatment cycle lasting 3 weeks Eligible participants will receive 4-6 cycles of study treatment Treatment may be terminated early in the event of the following disease progression intolerable toxicity initiation of new anti-tumor therapy withdrawal of informed consent loss to follow-up death or any other circumstances meeting the criteria for treatment discontinuation whichever occurs first
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