NCT02992483

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

December 12, 2016

Last Update Submit

July 27, 2021

Conditions

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

Keywords

multiple myelomalymphomadlbcl

Outcome Measures

Primary Outcomes (5)

  • Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.

    2 years

  • Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only

    2 years

  • Tolerability: Dose interruptions

    2 years

  • Tolerability: Dose reductions

    2 years

  • Tolerability: Dose intensity

    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

    2 years

  • Area Under Curve (AUC)

    2 years

  • Maximum Plasma Concentration (Cmax)

    2 years

  • Terminal elimination half-life (T1/2)

    2 years

  • Apparent volume of distribution (Vz)

    2 years

  • +3 more secondary outcomes

Study Arms (1)

MIK665

EXPERIMENTAL
Drug: MIK665

Interventions

MIK665DRUG

MIK665

Also known as: S64315
MIK665

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.

You may not qualify if:

  • Known history of chronic liver disease
  • History of chronic pancreatitis.
  • Prior treatment with Mcl-1 inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

MD Anderson Cancer Center/University of Texas MD Anderson CC

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 811-1395, Japan

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

July 12, 2017

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)ES(1)US(1)FR(1)IT(1)AU(1)DE(2)