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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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ClinicalTrials.gov Identifier: NCT02992483
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma Drug: MIK665 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 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 : July 12, 2017
Estimated Primary Completion Date : April 28, 2020
Estimated Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MIK665 Drug: MIK665
MIK665
Other Name: S64315


Outcome Measures
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Primary Outcome Measures :
  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 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 [ 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992483


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Ohio
Novartis Investigative Site Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
Australia, Victoria
Novartis Investigative Site Recruiting
Heidelberg, Victoria, Australia, 3084
France
Novartis Investigative Site Recruiting
Nantes Cedex 1, France, 44093
Germany
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Italy
Novartis Investigative Site Recruiting
Rozzano, MI, Italy, 20089
Japan
Novartis Investigative Site Recruiting
Fukuoka-city, Fukuoka, Japan, 811-1395
Spain
Novartis Investigative Site Recruiting
Salamanca, Castilla Y Leon, Spain, 37007
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02992483     History of Changes
Other Study ID Numbers: CMIK665X2101
2016-003624-22 ( EudraCT Number )
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
multiple myeloma
lymphoma
dlbcl

Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin