Olaparib With Ceralasertib in Recurrent Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT04417062|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : December 2, 2020
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:
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Osteosarcoma Recurrent||Drug: Olaparib Drug: Ceralasertib||Phase 2|
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 12-30 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:
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Olaparib in Combination With Ceralasertib in Patients With Recurrent Osteosarcoma|
|Actual Study Start Date :||November 24, 2020|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||June 1, 2025|
Unresectable disease (can not be surgically removed) will be enrolled into Cohort 1 and Resectable disease (can be surgically removed) which is limited only to the lung parenchyma will be enrolled into Cohort 2.
Patients can remain on treatment for up to 2 years if disease progression has not occurred.
Olaparib is taken by mouth, twice daily through out the 28 day study cycle.
Other Name: Lynparza
Ceralasertib is taken by mouth, once daily on days 1-7 of the study cycle.
Other Name: AZD6738
- Cohort 1 Event Free at 4 months [ Time Frame: 4 months after start of protocol therapy ]Simon's two-stage design will be applied to the primary (binary) endpoint, event-free at 4-months. An event is defined as the occurrence of relapse, disease progression as defined by RECIST 1.1, or death from any cause.
- Cohort 2 paired pre-/post-treatment tumor Assessment [ Time Frame: 4 months after start of protocol therapy ]Estimate the proportion of patients who have paired pre-/post-treatment tumor samples adequate for biomarker studies and / or derivation of PDX models.
- Objective Response Rate [ Time Frame: 2 years ]Radiographic response according to RECIST criteria. confidence interval on the proportion.
- Event Free Survival [ Time Frame: time from registration to the earlier of progression, relapse, or death due to any cause up to 4 years ]An event is defined as progression, relapse, or death from any cause
- Overall Survival [ Time Frame: From registration until death from any cause up to 4 years ]Defined as death from any cause
- Cohort 2 Event Free Survival 12 months [ Time Frame: 12 months ]Within Cohort 2, calculate the proportion who are event-free at 12- months, as the total number event-free at 12-months divided by the number of evaluable patients.
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 [ Time Frame: enrollment until 30 days after last dose of study treatment up to 24 Months ]The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade. This analysis will be performed overall and separately for Cohort 1 and 2. Within a given patient, a given adverse event will be counted only once at the highest grade.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417062
|Contact: Katherine Janeway, MD||617-632-4296||KJANEWAY@PARTNERS.ORG|
|United States, Massachusetts|
|Dana Farber Cancer Institite||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Katherine Janeway, MD 617-632-4296 KJANEWAY@PARTNERS.ORG|
|Principal Investigator: Katherine Janeway, MD|
|Principal Investigator:||Katherine Janeway, MD||Dana-Farber Cancer Institute|