Onvansertib + Paclitaxel In TNBC

Status Recruiting

Clinical Trial 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

Clinical Trial Description

This is a phase 1b/2 study of onvansertib in combination with paclitaxel in patients with triple negative invasive breast cancer with unresectable locally advanced or metastatic disease. In the phase 1b, different doses of onvansertib will be studied with a fixed dose of paclitaxel to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of onvansertib. In the phase 2, the selected onvansertib RP2D in combination with paclitaxel will be studied following a Simon two-stage design. 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 Participants will receive study treatment for as long there are no serious side effects and the disease does not get worse. It is expected that about 50 people will take part in this research study. This is a Phase 1/2 clinical trial. A Phase 1 clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved Paclitaxel as a treatment option for this disease. The use of Onvansertib is experimental which means that it is not approved by any regulatory authority, including the FDA, for treatment of metastatic breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05383196
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Antonio Giordano, MD, PhD
Phone	(617) 632-3800
Email	antonio_giordano@dfci.harvard.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	September 30, 2022
Completion date	February 15, 2029

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.