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NCT04720664 · ClinicalTrials.gov registry record · Phase 2
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04720664: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT04720664 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04720664, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
Anti-tumor efficacy will be defined as partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions assessed by CT or MRI. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diame
Interventions
- DRUG SM-88
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
Why NCT04720664 stopped before completion
NCT04720664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which SM-88 is the first listed.
NCT04720664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04720664 about?
NCT04720664 is a clinical study titled "Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer". 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 us...
What is the current status of trial NCT04720664?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2021-09-22. Estimated completion is 2023-02-10.
What interventions are being tested in trial NCT04720664?
The interventions under investigation include: SM-88 (DRUG).
Who is sponsoring clinical trial NCT04720664?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04720664's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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