Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer

Part of paid clinical trials in Norwalk, Connecticut.

Sponsor
OncoTherapy Science, Inc.
Study ID
NCT02926690
Phase
PHASE1
Status
Recruiting

Conditions

  • Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OTS167PO — DRUG
    Single arm, no competitor

Study Details

The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer.

Key Dates

Start date
May 29, 2017
Status verified
Mar 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OTS167PO

Primary Outcome Measure

MTD [ Time Frame: During Cycle1 after the first administration ]

Locations (8)

FacilityCityStateZIPSite coordinators
Norwalk HospitalNorwalkConnecticut06856-
Emory University, Winship Cancer InstituteAtlantaGeorgia30322
Madison Steininger
404-778-8145
Shipra Gandhi, MD, MS (PRINCIPAL_INVESTIGATOR)
Kapi'olani Medical Center for Women & ChildrenHonoluluHawaii96826
Robyn Morse
808-212-3440
Naoto Ueno, MD, PhD, FACP (PRINCIPAL_INVESTIGATOR)
Jami Fukui, MD (SUB_INVESTIGATOR)
Dartmouth Cancer Center/Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Courtney Davis
603-653-9089
Lauren Sinks
603-650-6380
Muhammad Z Afzal, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York11065-
Weill Cornell Medicine | NewYork-PresbyterianNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
MCW Cancer Center Clinical Trials Office
414-805-8900
Yee Chung Cheng, MD (PRINCIPAL_INVESTIGATOR)

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