Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT02562612
Status:
WITHDRAWN
Last Update Posted:
2022-07-01
First Post:
2015-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of SM-88 in Advanced Cancers
Sponsor:
Tyme, Inc
Organization:
Study Overview
Official Title:
Ascending Multi-Dose Clinical Trial to Assess the Pharmacokinetics Efficacy of SM-88 Oral Administration in Breast Cancer Subjects
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated. Never established sites or enrolled subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.
Detailed Description:
The primary objective of this clinical trial is to assess the response rate and PFS in previously treated breast cancer patients. Additional objectives include the pharmacokinetics of multiple ascending doses of SM-88, a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. Secondary objectives of this study include an assessment of safety and tolerability of ascending doses of orally administered SM-88. Additional response data will also be collected.
Study Oversight
Has Oversight DMC:
False
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?: