CompletedPhase 1

Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

United States, Australia, France31 participantsStarted 2017-07-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 2 years

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

Timeframe: 2 years

Tolerability: Dose interruptions

Timeframe: 2 years

Tolerability: Dose reductions

Timeframe: 2 years

Tolerability: Dose intensity

Timeframe: 2 years

Trial details

NCT IDNCT02992483

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-07

View on ClinicalTrials.gov More Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma trials