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Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer

NCT04720664 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-08-28

Study results available
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Summary

This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.

Conditions

Interventions

DRUG

SM-88

* SM-88, Two 230 mg capsules taken orally twice daily (920 mg daily). * Methoxsalen, One 10 mg capsule taken orally once daily. * Phenytoin, One 50 mg tablet taken orally once daily. * Sirolimus, One 0.5 mg tablet taken orally once daily.

Sponsors & Collaborators

  • Tyme, Inc

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Nadia Ashai, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2023-02-10
Completion
2023-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720664 on ClinicalTrials.gov