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NCT03471663 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by InventisBio Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 15
- Study locations
NCT03471663: Completed Phase 1 study of Breast Cancer, sponsored by InventisBio Co..
NCT03471663 is a Phase 1 study of Breast Cancer that has completed, run by InventisBio Co.. The registered enrollment target is 200 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03471663, a Phase 1 study of Breast Cancer, has completed, sponsored by InventisBio Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Conditions Studied
Interventions
- DRUG palbociclib
- DRUG D-0502
Study Locations (15)
Texas
- Local Institution - Dallas
- Local Institution - San Antonio
- Local Institution - San Antonio
- Local Institution - Tyler
California
- Local Institution - Fresno
Colorado
- Local Institution - Aurora
Connecticut
- Local Institution - New Haven
Massachusetts
- Local Institution - Boston
Oregon
- Local Institution - Eugene
South Carolina
- Local Institution - Greenville
Tennessee
- Local Institution - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2018-03-18 |
| Est. Completion | 2023-10-18 |
| Phase | Phase 1 |
What the finished NCT03471663 record still lists
NCT03471663 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which palbociclib is the first listed.
NCT03471663 lists 15 locations in 12 states (Texas, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03471663 about?
NCT03471663 is a clinical study titled "A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer". This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic E...
What is the current status of trial NCT03471663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2018-03-18. Estimated completion is 2023-10-18.
What conditions does trial NCT03471663 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03471663?
The interventions under investigation include: palbociclib (DRUG), D-0502 (DRUG).
Who is sponsoring clinical trial NCT03471663?
This trial is sponsored by InventisBio Co., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03471663 being conducted?
This trial has 15 study locations across California, Colorado, Connecticut, Massachusetts, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03471663's enrollment target sits among peer trials
200 362nd of 1224 higher than 841 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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