Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02338349 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
A Phase 1 study, sponsored by Stemline Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT02338349: Completed Phase 1 study, sponsored by Stemline Therapeutics.
NCT02338349 is a Phase 1 study that has completed, run by Stemline Therapeutics. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338349, a Phase 1 study, has completed, sponsored by Stemline Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.
Interventions
- DRUG Elacestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-04 |
| Phase | Phase 1 |
What the finished NCT02338349 record still lists
NCT02338349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Elacestrant is the first listed.
NCT02338349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02338349 about?
NCT02338349 is a clinical study titled "A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer". The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
What is the current status of trial NCT02338349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2015-01. Estimated completion is 2020-04.
What interventions are being tested in trial NCT02338349?
The interventions under investigation include: Elacestrant (DRUG).
Who is sponsoring clinical trial NCT02338349?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02338349's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03521830 · 57 participants · Phase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- NCT03587701 · 57 participants · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT04104126 · 57 participants · NA
Blood Flow Restriction Therapy in Achilles Injury
- NCT04703842 · 57 participants · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia