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 :
Completed
First Posted : December 14, 2016
Last Update Posted : August 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma | Drug: MIK665 | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
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 : | July 12, 2017 |
Actual Primary Completion Date : | June 7, 2019 |
Actual Study Completion Date : | June 7, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: MIK665 |
Drug: MIK665
MIK665
Other Name: S64315 |
- Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs. [ Time Frame: 2 years ]
- Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only [ Time Frame: 2 years ]
- Tolerability: Dose interruptions [ Time Frame: 2 years ]
- Tolerability: Dose reductions [ Time Frame: 2 years ]
- Tolerability: Dose intensity [ Time Frame: 2 years ]
- 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 ]
- Area Under Curve (AUC) [ Time Frame: 2 years ]Plasma PK parameter
- Maximum Plasma Concentration (Cmax) [ Time Frame: 2 years ]Plasma PK parameter
- Terminal elimination half-life (T1/2) [ Time Frame: 2 years ]Plasma PK parameter
- Apparent volume of distribution (Vz) [ Time Frame: 2 years ]Plasma PK parameter
- Clearance (CL) [ Time Frame: 2 years ]Plasma PK parameter
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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
United States, Texas | |
MD Anderson Cancer Center/University of Texas MD Anderson CC | |
Houston, Texas, United States, 77030 | |
Australia, Victoria | |
Novartis Investigative Site | |
Heidelberg, Victoria, Australia, 3084 | |
France | |
Novartis Investigative Site | |
Nantes Cedex 1, France, 44093 | |
Germany | |
Novartis Investigative Site | |
Heidelberg, Germany, 69120 | |
Novartis Investigative Site | |
Kiel, Germany, 24105 | |
Italy | |
Novartis Investigative Site | |
Rozzano, MI, Italy, 20089 | |
Japan | |
Novartis Investigative Site | |
Fukuoka-city, Fukuoka, Japan, 811-1395 | |
Spain | |
Novartis Investigative Site | |
Salamanca, Castilla Y Leon, Spain, 37007 |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02992483 |
Other Study ID Numbers: |
CMIK665X2101 2016-003624-22 ( EudraCT Number ) |
First Posted: | December 14, 2016 Key Record Dates |
Last Update Posted: | August 3, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
multiple myeloma lymphoma dlbcl |
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 |