Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05383196 · ClinicalTrials.gov registry record · Phase 1

Onvansertib + Paclitaxel In TNBC

A Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Antonio Giordano, MD.

Active
Registry status
Phase 1
Development phase
50
Enrollment target
3
Study locations

NCT05383196: Active Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Antonio Giordano, MD.

NCT05383196 is a Phase 1 study of Breast Cancer and Metastatic Breast Cancer that is active but no longer recruiting, run by Antonio Giordano, MD. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05383196, a Phase 1 study of Breast Cancer and Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Antonio Giordano, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
3
Study locations

Study 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

Primary Outcome

DLTs will be defined as toxicities that are considered at least possibly related to the study regimen and that fit one or more of the criteria defined per protocol

Interventions

  • DRUG Paclitaxel
  • DRUG Onvansertib

Study Locations (3)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconness Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-09-30
Est. Completion 2029-02-15
Phase Phase 1
Antonio Giordano, MD

1 total trials

What the registry record for NCT05383196 still lists

NCT05383196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.

NCT05383196 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05383196 about?

NCT05383196 is a clinical study titled "Onvansertib + Paclitaxel In TNBC". 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

What is the current status of trial NCT05383196?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-09-30. Estimated completion is 2029-02-15.

What conditions does trial NCT05383196 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Cancer, Invasive Breast Cancer, Triple Negative Breast Cancer (TNBC).

What interventions are being tested in trial NCT05383196?

The interventions under investigation include: Paclitaxel (DRUG), Onvansertib (DRUG).

Who is sponsoring clinical trial NCT05383196?

This trial is sponsored by Antonio Giordano, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05383196 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05383196's enrollment target sits among peer trials

50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00200889 · 50 participants · Early Phase 1

    Mapping Auricular Vagus Nerve Circuitry

  • NCT00409435 · 50 participants · Phase 2

    A Study of Pyridostigmine in Postural Tachycardia Syndrome

  • NCT01202305 · 50 participants

    The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

  • NCT01225913 · 50 participants · Phase 4

    Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05383196, the US trial registry maintained by the National Library of Medicine. NCT05383196 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.