Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | July 12, 2017 |
| End Date: | April 28, 2020 |
| Contact: | Novartis Pharmaceuticals |
| Email: | Novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
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.
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.
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.
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.
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.
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