Skip to main content
OpenTrials
Completed

NCT Number: NCT02992483

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Heidelberg, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIK665

Drug

MIK665

Other names: S64315

Primary outcomes

  1. Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.

    Time frame: 2 years

  2. Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only

    Time frame: 2 years

  3. Tolerability: Dose interruptions

    Time frame: 2 years

  4. Tolerability: Dose reductions

    Time frame: 2 years

  5. Tolerability: Dose intensity

    Time frame: 2 years

Secondary outcomes

  1. 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

  2. Area Under Curve (AUC)

    Time frame: 2 years

    Plasma PK parameter

  3. Maximum Plasma Concentration (Cmax)

    Time frame: 2 years

    Plasma PK parameter

  4. Terminal elimination half-life (T1/2)

    Time frame: 2 years

    Plasma PK parameter

  5. Apparent volume of distribution (Vz)

    Time frame: 2 years

    Plasma PK parameter

  6. Clearance (CL)

    Time frame: 2 years

    Plasma PK parameter

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.