RecruitingPhase 1NCT02926690

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

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer


Sponsor

OncoTherapy Science, Inc.

Enrollment

70 participants

Start Date

May 29, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug that blocks a protein called MELK (which helps cancer cells divide and grow) in women with advanced or metastatic breast cancer, including triple-negative breast cancer (a particularly aggressive form with fewer treatment options). **You may be eligible if...** - You are a female 18 years of age or older - You have been diagnosed with locally advanced or metastatic breast cancer (cancer that has spread beyond the breast) - Your cancer has stopped responding to standard treatments or no standard treatment is available - Your cancer has been confirmed by biopsy **You may NOT be eligible if...** - You have not yet tried standard treatment options - You have certain serious heart, liver, or kidney conditions - You are pregnant or breastfeeding This study may open up new options particularly for triple-negative breast cancer patients, who often have the fewest treatment choices. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOTS167PO

Single arm, no competitor


Locations(8)

Norwalk Hospital

Norwalk, Connecticut, United States

Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, United States

Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Weill Cornell Medicine | NewYork-Presbyterian

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT02926690