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

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

ClinicalTrials.gov Identifier: NCT02992483

Novartis Reference Number: CMIK665X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
67 participants
Start date 
Jul 12, 2017
Completion date 
May 31, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MIK665
MIK665

Eligibility 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.

Study Locations

United States
Ohio State University Medical Center Main Site
Withdrawn
Columbus, 43210
Ohio
United States
MD Anderson Cancer Center/University of Texas MD Anderson CC
Recruiting
Houston, 77030
Texas
United States
Australia
Novartis Investigative Site
Completed
Heidelberg, 3084
Victoria
Australia
France
Novartis Investigative Site
Withdrawn
Creteil, 94010
-
France
Novartis Investigative Site
Completed
Nantes Cedex 1, 44093
-
France
Germany
Novartis Investigative Site
Completed
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Completed
Kiel, 24105
-
Germany
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Completed
Fukuoka-city, 811-1395
Fukuoka
Japan
Spain
Novartis Investigative Site
Active, not recruiting
Salamanca, 37007
Castilla Y Leon
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]