Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-12 @ 1:03 PM
Study NCT ID:
NCT03618602
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients
Sponsor:
Shanghai Theorion Pharmaceutical Co Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
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 first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients.
Detailed Description:
This is a first-in-human, single center, open-label, single arm, dose escalating phase I study. This study will be conducted in 3 parts.
Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety.
Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety
Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects.
Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety.
Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety
Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects.
Study Oversight
Has Oversight DMC:
False
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?: