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

NCT02992483

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: CMIK665X2101
  • SECONDARY ID: 2016-003624-22
  • NCT ID: NCT02992483

Conditions

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

Interventions

DrugSynonymsArms
MIK665S64315MIK665

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
MIK665Experimental
  • MIK665

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Time Frame:2 years
Safety Issue:
Description:
Measure:Area Under Curve (AUC)
Time Frame:2 years
Safety Issue:
Description:Plasma PK parameter
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:2 years
Safety Issue:
Description:Plasma PK parameter
Measure:Terminal elimination half-life (T1/2)
Time Frame:2 years
Safety Issue:
Description:Plasma PK parameter
Measure:Apparent volume of distribution (Vz)
Time Frame:2 years
Safety Issue:
Description:Plasma PK parameter
Measure:Clearance (CL)
Time Frame:2 years
Safety Issue:
Description:Plasma PK parameter
Measure: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
Time Frame:2 years
Safety Issue:
Description:
Measure: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
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • multiple myeloma
  • lymphoma
  • dlbcl

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