NCT03618602

Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Theorion Pharmaceutical Co Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Multiple Myeloma
• Recurrent Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bisthianostat	Bisthianostat is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.

Timeline

• Start date: 2018-04-25
• Primary completion: 2020-04-01
• Completion: 2020-07-01
• First posted: 2018-08-07
• Last updated: 2019-09-19

Locations

1 site across 1 country: China