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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02992483
Ethics application status
Date submitted
12/12/2016
Date registered
14/12/2016

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)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Terminal elimination half-life (T1/2)
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Apparent volume of distribution (Vz)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Clearance (CL)
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2019
Sample size
Target
Accrual to date
Final
31
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
Texas
Country [2] 0 0
France
State/province [2] 0 0
Nantes Cedex 1
Country [3] 0 0
Germany
State/province [3] 0 0
Heidelberg
Country [4] 0 0
Germany
State/province [4] 0 0
Kiel
Country [5] 0 0
Italy
State/province [5] 0 0
MI
Country [6] 0 0
Japan
State/province [6] 0 0
Fukuoka
Country [7] 0 0
Spain
State/province [7] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02992483