Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma Clinical Trial
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
| Verified date | July 2021 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | June 7, 2019 |
| Est. primary completion date | June 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Heidelberg | Victoria |
| France | Novartis Investigative Site | Nantes Cedex 1 | |
| Germany | Novartis Investigative Site | Heidelberg | |
| Germany | Novartis Investigative Site | Kiel | |
| Italy | Novartis Investigative Site | Rozzano | MI |
| Japan | Novartis Investigative Site | Fukuoka-city | Fukuoka |
| Spain | Novartis Investigative Site | Salamanca | Castilla Y Leon |
| United States | MD Anderson Cancer Center/University of Texas MD Anderson CC | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, France, Germany, Italy, Japan, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs. | 2 years | ||
| Primary | Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only | 2 years | ||
| Primary | Tolerability: Dose interruptions | 2 years | ||
| Primary | Tolerability: Dose reductions | 2 years | ||
| Primary | Tolerability: Dose intensity | 2 years | ||
| Secondary | 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 | 2 years | ||
| Secondary | Area Under Curve (AUC) | Plasma PK parameter | 2 years | |
| Secondary | Maximum Plasma Concentration (Cmax) | Plasma PK parameter | 2 years | |
| Secondary | Terminal elimination half-life (T1/2) | Plasma PK parameter | 2 years | |
| Secondary | Apparent volume of distribution (Vz) | Plasma PK parameter | 2 years | |
| Secondary | Clearance (CL) | Plasma PK parameter | 2 years | |
| Secondary | 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 | 2 years | ||
| Secondary | 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 | 2 years |