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NCT04997993 · ClinicalTrials.gov registry record · Phase 1
Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer
A Phase 1 study of PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer, sponsored by Deborah Doroshow.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04997993: Recruiting Phase 1 study of PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer, sponsored by Deborah Doroshow.
NCT04997993 is a Phase 1 study of PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer that is actively recruiting participants, run by Deborah Doroshow. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04997993, a Phase 1 study of PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer, is actively recruiting participants, sponsored by Deborah Doroshow.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is to assess preliminary evidence of clinical activity of leflunomide in these patient populations.
Primary Outcome
Grade 3 or higher non-hematologic toxicity, Any death not clearly due to the underlying disease, Cases defined by Hy's law, Grade 4 neutropenia or thrombocytopenia \> 7 days, Grade 3 thrombocytopenia with clinically significant bleeding, Febrile neutropenia
Conditions Studied
Interventions
- DRUG Leflunomide
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT04997993 shows while recruiting
NCT04997993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Leflunomide is the first listed.
NCT04997993 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04997993 about?
NCT04997993 is a clinical study titled "Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer". Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is t...
What is the current status of trial NCT04997993?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-12-13. Estimated completion is 2027-12.
What conditions does trial NCT04997993 study?
This clinical trial studies the following conditions: PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer.
What interventions are being tested in trial NCT04997993?
The interventions under investigation include: Leflunomide (DRUG).
Who is sponsoring clinical trial NCT04997993?
This trial is sponsored by Deborah Doroshow, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04997993 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04997993's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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