Trials / Active Not Recruiting
Active Not RecruitingNCT04288089
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
An Open-Label Multicenter Phase 1b Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive HER2-Negative Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib (75, 100, 125 milligram [mg]) | Palbociclib orally, once daily (QD). |
| DRUG | H3B-6545 (150, 300, 450 mg) | H3B-6545 orally, QD. |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2022-09-16
- Completion
- 2027-03-31
- First posted
- 2020-02-27
- Last updated
- 2026-02-27
- Results posted
- 2024-03-22
Locations
8 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04288089. Inclusion in this directory is not an endorsement.