Onvansertib + Paclitaxel In TNBC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Antonio Giordano, MD
Study ID
NCT05383196
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Breast Cancer
  • HER2-negative Breast Cancer
  • Hormone Receptor Negative Breast Carcinoma
  • Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer
  • Inflammatory Breast Cancer
  • Invasive Breast Cancer
  • Locally Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
  • Unresectable Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Onvansertib — DRUG
    oral administration, once daily for 21 consecutive days, followed by 7 days without drug, to complete a cycle of 28 days.
  • Paclitaxel — DRUG
    once a week into your vein (by intravenous infusion) over about 30 minutes. This will continue for 3 weeks of every cycle

Study Details

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

Key Dates

Start date
Sep 30, 2022
Status verified
Feb 2026
Primary completion
Dec 15, 2026
Completion
Feb 15, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DOSE ESCALATION ONVANSERTIB + PACLITAXEL
    In the phase 1b, dose escalation/de-escalation will be managed using a BOIN design to identify the RP2D. The study is divided into three time periods: a screening period; a treatment period; and a post-treatment follow-up period. The names of the study interventions involved in this study are: * Onvansertib * Paclitaxel
  • Experimental: DOSE EXPANSION RP2D ONVANSERTIB + PACLITAXEL
    The study is divided into three time periods: a screening period; a treatment period; and a post-treatment follow-up period. The names of the study interventions involved in this study are: * Onvansertib * Paclitaxel

Primary Outcome Measure

Dose-Limiting Toxicity (DLT)-Phase Ib [ Time Frame: during the first cycle of therapy (28 days). ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconness Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconness Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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