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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02992483
Collaborator
(none)
31
Enrollment
8
Locations
1
Arm
22.8
Actual Duration (Months)
3.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 12, 2017
Actual Primary Completion Date :
Jun 7, 2019
Actual Study Completion Date :
Jun 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: MIK665

Drug: MIK665
MIK665
Other Names:
  • S64315

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs. [2 years]

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

    3. Tolerability: Dose interruptions [2 years]

    4. Tolerability: Dose reductions [2 years]

    5. Tolerability: Dose intensity [2 years]

    Secondary Outcome Measures

    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 [2 years]

    2. Area Under Curve (AUC) [2 years]

      Plasma PK parameter

    3. Maximum Plasma Concentration (Cmax) [2 years]

      Plasma PK parameter

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

      Plasma PK parameter

    5. Apparent volume of distribution (Vz) [2 years]

      Plasma PK parameter

    6. Clearance (CL) [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 [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 [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center/University of Texas MD Anderson CC Houston Texas United States 77030
    2 Novartis Investigative Site Heidelberg Victoria Australia 3084
    3 Novartis Investigative Site Nantes Cedex 1 France 44093
    4 Novartis Investigative Site Heidelberg Germany 69120
    5 Novartis Investigative Site Kiel Germany 24105
    6 Novartis Investigative Site Rozzano MI Italy 20089
    7 Novartis Investigative Site Fukuoka-city Fukuoka Japan 811-1395
    8 Novartis Investigative Site Salamanca Castilla Y Leon Spain 37007

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02992483
    Other Study ID Numbers:
    • CMIK665X2101
    • 2016-003624-22
    First Posted:
    Dec 14, 2016
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    multiple myeloma
    lymphoma
    dlbcl
    Additional relevant MeSH terms:
    Lymphoma
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Aug 3, 2021