Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02992483
  4. Details
NCT02992483 Clinical Trial

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

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

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02992483
Other study ID # CMIK665X2101
Secondary ID 2016-003624-22
Status Completed
Phase Phase 1
First received
Last updated
Start date July 12, 2017
Est. completion date June 7, 2019

Study information
Verified date July 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date June 7, 2019
Est. primary completion date June 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• MIK665
MIK665

Locations
Country Name City State
Australia Novartis Investigative Site Heidelberg Victoria
France Novartis Investigative Site Nantes Cedex 1
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Kiel
Italy Novartis Investigative Site Rozzano MI
Japan Novartis Investigative Site Fukuoka-city Fukuoka
Spain Novartis Investigative Site Salamanca Castilla Y Leon
United States MD Anderson Cancer Center/University of Texas MD Anderson CC Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Japan,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs. 2 years
Primary Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only 2 years
Primary Tolerability: Dose interruptions 2 years
Primary Tolerability: Dose reductions 2 years
Primary Tolerability: Dose intensity 2 years
Secondary 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
Secondary Area Under Curve (AUC) Plasma PK parameter 2 years
Secondary Maximum Plasma Concentration (Cmax) Plasma PK parameter 2 years
Secondary Terminal elimination half-life (T1/2) Plasma PK parameter 2 years
Secondary Apparent volume of distribution (Vz) Plasma PK parameter 2 years
Secondary Clearance (CL) Plasma PK parameter 2 years
Secondary 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
Secondary 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

External Links