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

Completed · Phase 1

Conditions studied: Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

In brief

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.

Key facts

Study ID

NCT02992483

Run by

Novartis Pharmaceuticals

People needed

31

Starts

2017-07-12

Expected to finish

2019-06-07

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
• Other Inclusion Criteria May Apply.

You may not qualify if…

• Known history of chronic liver disease
• History of chronic pancreatitis.
• Prior treatment with Mcl-1 inhibitor.
• Other Exclusion Criteria May Apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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