Onvansertib + Paclitaxel In TNBC
NCT05383196 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-11
Summary
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
The names of the study interventions involved in this study are:
* Onvansertib
* Paclitaxel
Conditions
- Breast Cancer
- Invasive Breast Cancer
- Unresectable Breast Carcinoma
- Locally Advanced Breast Cancer
- Metastatic Breast Cancer
- Inflammatory Breast Cancer
- Triple Negative Breast Cancer (TNBC)
- Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer
- HER2-negative Breast Cancer
- Hormone Receptor Negative Breast Carcinoma
Interventions
- DRUG
-
oral administration, once daily for 21 consecutive days, followed by 7 days without drug, to complete a cycle of 28 days.
- DRUG
-
once a week into your vein (by intravenous infusion) over about 30 minutes. This will continue for 3 weeks of every cycle
Sponsors & Collaborators
-
Cardiff Oncology
collaborator INDUSTRY -
Antonio Giordano, MD
lead OTHER
Principal Investigators
-
Antonio C Giordano, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-30
- Primary Completion
- 2026-12-15
- Completion
- 2029-02-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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