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SM-88 for Breast Cancer (OASIS Trial)

Phase 2
Waitlist Available
Led By Julie Collins, MD MPH
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal or postmenopausal female or male patients 18 years of age or older.
Life expectancy of more than 3 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months)
Awards & highlights

OASIS Trial Summary

This trial is testing a new combo treatment for metastatic breast cancer. They want to see if it's effective and has acceptable side effects.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer

OASIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a man or woman who is 18 years or older, whether or not you have gone through menopause.
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You are expected to live for at least 3 more months.

OASIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR) at ≥ 24 Weeks
Duration of Response (DOR)
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
+1 more
Other outcome measures
Changes in cell free DNA (cfDNA)

OASIS Trial Design

1Treatment groups
Experimental Treatment
Group I: oral SM-88Experimental Treatment1 Intervention
SM-88 taken with three conditioning agents: methoxsalen, phenytoin, and sirolimus

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,491 Total Patients Enrolled
33 Trials studying Breast Cancer
13,074 Patients Enrolled for Breast Cancer
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
186 Total Patients Enrolled
1 Trials studying Breast Cancer
Julie Collins, MD MPHPrincipal InvestigatorGeorgetown University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant pool size for this clinical examination?

"Indeed, the clinicaltrials.gov website confirms that this medical investigation is actively seeking participants after being initially released on September 22nd 2021 and last updated on November 2nd 2022. The trial requires 50 patients from 5 different sites to contribute data."

Answered by AI

Is SM-88 a safe drug to administer to individuals?

"There is some evidence of SM-88's safety, giving it an appraisal of 2 on the risk scale. However, there are no studies yet that confirm its efficacy in treating cancer."

Answered by AI

Are there any unfilled roles in this medical experiment?

"Accurate. Clinicaltrials.gov reports that this clinical trial is actively seeking participants, having first been posted on September 22nd 2021 and lastly amended on November 2nd 2022."

Answered by AI
~3 spots leftby Mar 2025