Clinical trial NCT03492125: A Study Of The Selective PKC-β Inhibitor MS- 553
Official title: A Phase I/II Dose-Escalation and Expansion Study of the Selective PKC-β Inhibitor MS-553 in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Aggressive Lymphoma
Lead sponsor: MingSight Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: a limited 3+3 phase 1 dose escalation study with expansion cohorts
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
timeFrame: Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort.
Secondary outcomes:
measure: The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy
timeFrame: Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Of Michigan Comprehensive Cancer Center
state: Michigan
city: New York
country: United States
facility: Columbia University, Herbert Irving Comprehensive Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University, James Comprehensive Cancer Center
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center, Department of Leukemia
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References: