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

First listed
May 20, 2022
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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