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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
NCT03471663 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03471663
The ClinicalTrials.gov registry entry for NCT03471663 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InventisBio Co., which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03471663 reports 15 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03471663?
The interventions under investigation include: palbociclib (DRUG), D-0502 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03471663?
This trial is sponsored by InventisBio Co., which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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