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

Phase 1

Completed

• Conditions: Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
• Interventions: Drug: MIK665

• Registration Number: NCT02992483
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Study Start: 2017-07-12
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIK665	MIK665	-

Primary Outcome Measures

Name	Time	Method
Tolerability: Dose interruptions	2 years
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.	2 years
Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only	2 years
Tolerability: Dose reductions	2 years
Tolerability: Dose intensity	2 years

Secondary Outcome Measures

Name	Time	Method
Best Overall response (BOR) per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma	2 years
Area Under Curve (AUC)	2 years	Plasma PK parameter
Maximum Plasma Concentration (Cmax)	2 years	Plasma PK parameter
Terminal elimination half-life (T1/2)	2 years	Plasma PK parameter
Apparent volume of distribution (Vz)	2 years	Plasma PK parameter
Clearance (CL)	2 years	Plasma PK parameter
Duration of Response (DOR)per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma	2 years
Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma	2 years

Trial Locations

Locations (2)

MD Anderson Cancer Center/University of Texas MD Anderson CC; 🇺🇸 Houston, Texas, United States

Novartis Investigative Site; 🇪🇸 Salamanca, Castilla Y Leon, Spain