Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
NCT ID: NCT02992483
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2017-07-12
2019-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MIK665
MIK665
MIK665
Interventions
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MIK665
MIK665
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
Exclusion Criteria
* History of chronic pancreatitis.
* Prior treatment with Mcl-1 inhibitor.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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MD Anderson Cancer Center/University of Texas MD Anderson CC
Houston, Texas, United States
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Kiel, , Germany
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Salamanca, Castille and León, Spain
Countries
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Related Links
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Other Identifiers
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2016-003624-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMIK665X2101
Identifier Type: -
Identifier Source: org_study_id
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