NCT02992483

Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

Phase I Open Label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacokinetics of Intravenously Administered MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.

Detailed description

The design of this phase I, open label, dose finding study was chosen in order to characterize the safety and tolerability of MIK665 and to determine the Maximal Tolerated Dose(s) (MTD(s)) and/or Recommended Dose(s) for Expansion (RDE(s)). This study will utilize a Bayesian Hierarchical model to guide dose escalation and estimate the MTD(s) based on the dose-DLT relationship(s) for MIK665 in the indications. The expansion part of the study will employ an open-label multiple arm design. The purpose of the expansion part is to further assess safety, tolerability, PK, PD and the anti-tumor activity of MIK665 at the selected RDE/s for Multiple Myeloma (MM) and MYC positive Diffuse large B-Cell Lymphoma (DLBCL) identified in the dose-escalation part.

Conditions

• Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

Interventions

Type	Name	Description
DRUG	MIK665	MIK665

Timeline

• Start date: 2017-07-12
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2016-12-14
• Last updated: 2021-08-03

Locations

8 sites across 7 countries: United States, Australia, France, Germany, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study