Olaparib With Ceralasertib in Recurrent Osteosarcoma

Status Recruiting

Clinical Trial Summary

This study is being done in order to evaluate the effectiveness of using two drugs (olaparib and ceralasertib) to treat patients with osteosarcoma that has not responded to treatment or has come back after treatment The names of the study drugs involved in this study are: - Olaparib - Ceralasertib

Clinical Trial Description

This is a single arm, phase 2, open-label clinical trial to evaluate the use of olaparib in combination with ceralasertib in 2 cohorts of patients aged 12-40 with recurrent osteosarcoma. The research study procedures include screening for eligibility, study treatment, evaluations and follow-up visits. - Cohort 1: Participants with unresectable osteosarcoma (unable to remove with surgery) - Cohort 2: Participants with lung only resectable osteosarcoma (able to remove with surgery) Participants will be given a drug diary to document information about the study treatment and study calender with information about what to expect during and between study visits. The names of the study drugs involved in this study are: - Olaparib - Ceralasertib Each treatment cycle lasts 28 days and participants will receive study treatment up to 24 cycles (2 years). It is expected that about 63 people will take part in this research study. - The study is looking to test: whether olaparib and ceralasertib given together are effective in patients with recurrent or refractory osteosarcoma. - how safe and how well tolerated olaparib and ceralasertib are when given together in patients with recurrent or refractory osteosarcoma. - markers in the blood and in tumor tissue to see if there are certain features of the tumor that may indicate this combination of drugs is effective or not effective. The U.S. Food and Drug Administration (FDA) has not approved Ceralasertib as a treatment for any disease. This is the first time that Ceralasertib will be given to children. The U.S. Food and Drug Administration (FDA) has not approved olaparib for recurrent osteosarcoma but it has been approved for other uses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04417062
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Katherine Janeway, MD
Phone	617-632-4994
Email	KJANEWAY@PARTNERS.ORG
Status	Recruiting
Phase	Phase 2
Start date	November 24, 2020
Completion date	June 1, 2025

View Details

See also
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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.