Trials / Completed
CompletedNCT03471663
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 I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- InventisBio Co., Ltd · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | D-0502 | oral tablets |
| DRUG | palbociclib | standard dose of palbociclib |
Timeline
- Start date
- 2018-03-18
- Primary completion
- 2023-10-18
- Completion
- 2023-10-18
- First posted
- 2018-03-20
- Last updated
- 2024-01-08
Locations
15 sites across 2 countries: United States, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03471663. Inclusion in this directory is not an endorsement.