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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02992483




Registration number
NCT02992483
Ethics application status
Date submitted
12/12/2016
Date registered
14/12/2016
Date last updated
22/06/2020

Titles & IDs
Public title
Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
2016-003624-22
Secondary ID [2] 0 0
CMIK665X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MIK665

Experimental: MIK665 -


Treatment: Drugs: MIK665
MIK665

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Tolerability: Dose interruptions
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Tolerability: Dose reductions
Timepoint [4] 0 0
2 years
Primary outcome [5] 0 0
Tolerability: Dose intensity
Timepoint [5] 0 0
2 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Area Under Curve (AUC) - Plasma PK parameter
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Maximum Plasma Concentration (Cmax) - Plasma PK parameter
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Terminal elimination half-life (T1/2) - Plasma PK parameter
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Apparent volume of distribution (Vz) - Plasma PK parameter
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Clearance (CL) - Plasma PK parameter
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
2 years

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Known history of chronic liver disease

- History of chronic pancreatitis.

- Prior treatment with Mcl-1 inhibitor.

- Other Exclusion Criteria May Apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
France
State/province [3] 0 0
Nantes Cedex 1
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Germany
State/province [5] 0 0
Kiel
Country [6] 0 0
Italy
State/province [6] 0 0
MI
Country [7] 0 0
Japan
State/province [7] 0 0
Fukuoka
Country [8] 0 0
Spain
State/province [8] 0 0
Castilla Y Leon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02992483
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
Novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02992483