Multiple Myeloma Clinical Trial

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

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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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years.
Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
Other Inclusion Criteria May Apply.

Exclusion Criteria

Known history of chronic liver disease
History of chronic pancreatitis.
Prior treatment with Mcl-1 inhibitor.
Other Exclusion Criteria May Apply.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT02992483

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 8 Locations for this study

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MD Anderson Cancer Center/University of Texas MD Anderson CC
Houston Texas, 77030, United States
Novartis Investigative Site
Heidelberg Victoria, 3084, Australia
Novartis Investigative Site
Nantes Cedex 1 , 44093, France
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Fukuoka-city Fukuoka, 811-1, Japan
Novartis Investigative Site
Salamanca Castilla Y Leon, 37007, Spain
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How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT02992483

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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