Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04814875
Status:
TERMINATED
Last Update Posted:
2024-02-14
First Post:
2021-03-04
Brief Title:
A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy
Sponsor:
THERAPIM PTY LTD
Organization:
THERAPIM PTY LTD
Study Overview
Official Title:
Phase 1b2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancer
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For technical reasons it was decided by the sponsor to close the ongoing ovarian cancer study AM ATX101-03 immediately
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b2a multicenter study which consists of two parts
Part 1 the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatinpegylated liposomal doxorubicin ACD ATX-101 will be administered intravenously in three escalation cohorts 20 30 and 45 mgm² according to a 33 design In the case where 20 mgm² is not tolerated the dose can be de-escalated to 15 mgm²
Part 2 the Phase 2a part of the study will investigate the efficacy and safety of ACD
ATX-101 will be administered at the dose defined in Part 1 of the study
Treatment will continue up to six cycles or until disease progression or unacceptable toxicity participant withdrawal of consent non-compliance lost to follow-up or withdrawal at the Investigators discretion whichever occurs first
Part 1 the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatinpegylated liposomal doxorubicin ACD ATX-101 will be administered intravenously in three escalation cohorts 20 30 and 45 mgm² according to a 33 design In the case where 20 mgm² is not tolerated the dose can be de-escalated to 15 mgm²
Part 2 the Phase 2a part of the study will investigate the efficacy and safety of ACD
ATX-101 will be administered at the dose defined in Part 1 of the study
Treatment will continue up to six cycles or until disease progression or unacceptable toxicity participant withdrawal of consent non-compliance lost to follow-up or withdrawal at the Investigators discretion whichever occurs first
Detailed Description:
None
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