Clinical Trials /

A Study Of The Selective PKC-β Inhibitor MS- 553

NCT03492125

Description:

A Phase I Dose-Escalation Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Of The Selective PKC-β Inhibitor MS- 553
  • Official Title: A Phase I Dose-Escalation Study Of The Selective PKC-β Inhibitor MS- 553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: MS-553-103
  • NCT ID: NCT03492125

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
MS-533high dose

Purpose

A Phase I Dose-Escalation Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Trial Arms

NameTypeDescriptionInterventions
low doseExperimentalMS-533
  • MS-533
mid low doseExperimentalMS-533
  • MS-533
mid high doseExperimentalMS-533
  • MS-533
high doseExperimentalMS-533
  • MS-533

Eligibility Criteria

        Inclusion Criteria:

        To be eligible for inclusion in the primary escalation and expansion cohort 1 in this
        study, patients must meet all of the following criteria:

          1. Age 18 years or older

          2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

               1. History of histologically documented CLL or SLL that meets IWCLL diagnostic
                  criteria according to the 2008 guidelines, and

               2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for
                  disease reduction prior to allogeneic transplantation

        Exclusion Criteria:

        Patients who meet any of the following criteria are not eligible for the primary escalation
        and expansion cohorts of this study:

          1. Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL),
             non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the
             inclusion criteria for the optional cohort.

          2. Active and uncontrolled autoimmune cytopenia(s)

          3. Any of the following prior therapies within 14 days prior to cycle 1, day 1:

               1. Major surgery

               2. Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used
                  by inhalation or topical route, or unless necessary for premedication before
                  iodinated contrast dye, or for autoimmune hemolytic anemia

               3. Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase
                  inhibitors for which no wash out is required (but must be stopped before cycle 1
                  day 1)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The primary objective of this study is to evaluate the safety of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy.
Time Frame:Assessments for DLT and TEAE will occur during cycle 1. The primary endpoint will be the rate of DLT and TEAE requiring study drug discontinuation in the first 28 days
Safety Issue:
Description:The primary endpoint of this study is the incidence rate of dose-limiting toxicities and treatment-emergent adverse events requiring study drug discontinuation

Secondary Outcome Measures

Measure:To evaluate the clinical activity (i.e. the overall response rate (ORR) of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy.
Time Frame:Screening, post cycle 3 and 6 cycles (each cycle is 28 days)
Safety Issue:
Description:This will be assessed according to the International Workshop on Chronic Lymphocytic Leukemia Response Criteria with modifications for treatment-related lymphocytosis.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:MingSight Pharmaceuticals, Inc.

Last Updated

April 24, 2019