Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaPhase 1NCT02992483
Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
A Phase 1 study testing MIK665 in people with Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, run by Novartis Pharmaceuticals at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
- What is being tested?
- MIK665
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 12 Jul 2017to 7 Jun 2019
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
- Other Inclusion Criteria May Apply.
Who cannot join
- Known history of chronic liver disease
- History of chronic pancreatitis.
- Prior treatment with Mcl-1 inhibitor.
- Other Exclusion Criteria May Apply.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Germany2 sites
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Kiel, 24105
United States1 site
MD Anderson Cancer Center/University of Texas MD Anderson CC
Houston, Texas, 77030
About this study
Official 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
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.
Read the detailed description
The design of this phase I, open label, dose finding study was chosen in order to characterize the safety and tolerability of MIK665 and to determine the Maximal Tolerated Dose(s) (MTD(s)) and/or Recommended Dose(s) for Expansion (RDE(s)).
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.
- Being tested
- MIK665
- Keywords
- multiple myeloma, lymphoma, dlbcl
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIK665Drug
Also called S64315
MIK665
| Study group | Role | What they receive |
|---|---|---|
| MIK665 | Experimental | Not described Receives: Drug: MIK665 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.
Measured: 2 years
Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only
Measured: 2 years
Tolerability: Dose interruptions
Measured: 2 years
Tolerability: Dose reductions
Measured: 2 years
Tolerability: Dose intensity
Measured: 2 years
Secondary outcomes (8)
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
Measured: 2 years
Area Under Curve (AUC)
Plasma PK parameter
Measured: 2 years
Maximum Plasma Concentration (Cmax)
Plasma PK parameter
Measured: 2 years
Terminal elimination half-life (T1/2)
Plasma PK parameter
Measured: 2 years
Apparent volume of distribution (Vz)
Plasma PK parameter
Measured: 2 years
Clearance (CL)
Plasma PK parameter
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start12 Jul 2017
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992483
- Sponsor's protocol ID
- CMIK665X2101
- Other IDs
- 2016-003624-22, 2016
- Status last verified
- Jul 2021
- First submitted
- 12 Dec 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No