Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04887298
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2021-05-04
Brief Title:
Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas STS with Pulmonary Metastases
Sponsor:
Moleculin Biotech Inc
Organization:
Moleculin Biotech Inc
Study Overview
Official Title:
Phase 1B2 Study of Liposomal Annamycin L-Annamycin in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a multi-center open-label single-arm study that in Phase 1b will determine the maximum tolerated dose MTD recommended phase 2 dose RP2D and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate
Detailed Description:
None
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