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Olaparib + Ceralasertib for Recurrent Osteosarcoma
Study Summary
This trial is being done to see if using these two drugs together can help patients with osteosarcoma who haven't responded to other treatments, or whose cancer has returned after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 220 Patients • NCT03106987Trial Design
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- I have used drugs that affect liver enzymes CYP3A4 or CYP2B6.Your doctor expects you to live for at least 4 months.You must agree to participate in the study before any study procedures can be done.I can do most daily activities by myself despite having had surgery for osteosarcoma.I am not taking any strong CYP3A enzyme stimulators.I have lung disease on one side and can provide a sample of my tumor.I do not have severe illnesses that could make treatment unsafe for me.I haven't had treatment for any other cancer in the last 3 years.I weigh more than 40 kg.I am willing and able to follow the study's requirements, including treatments and visits.I am between 13 and 40 years old.I don't have any lasting side effects from previous treatments that are moderate or worse.Surgery for my disease is not possible without major risks and no other standard treatments are available.I have not had heart disease in the past 6 months.I finished any palliative radiotherapy (not to the lung) over a week ago.I am mostly active and can care for myself, with no recent decline.I do not have any uncontrolled illnesses like heart failure or severe infections.I am not taking strong or moderate drugs that affect liver enzymes.I have been diagnosed with ataxia telangiectasia.I have had lung radiation therapy before.I have been taking a specific dose of corticosteroids within the last 14 days.My heart's pumping ability is below normal.My doctors believe they can remove all my lung metastases through surgery.I have not had immunotherapy in the last 42 days.I can understand and agree to the study's details, or I have someone who can consent for me if I'm a minor.I haven't had chemotherapy or targeted therapy in the last 21 days.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I have not had major surgery in the last 2 weeks.I have factors that could increase my heart's risk of irregular rhythm.I am not pregnant or breastfeeding.My kidney, liver, and bone marrow are functioning normally.I am a man willing to use condoms during the study and for 1 week after it ends.My osteosarcoma was confirmed through tissue examination.My lung cancer has come back at least once but is still only in my lungs.I have taken a pregnancy test within the last 28 days and it was negative.My condition has not improved or has worsened despite treatment.I am not using effective birth control.My brain or spinal tumors are treated, stable, and I haven't needed steroids for 4 weeks.I plan to use herbal medications within a week before starting the study treatment.I have ongoing issues with nausea, vomiting, or have had major surgery on my intestines.I have brain metastases that are causing symptoms and are not under control.I have recovered from side effects of my previous cancer treatments.I can swallow pills whole.I experience significant drops in blood pressure when standing.I have been diagnosed with a specific condition.
- Group 1: Olaparib-Ceralasertib
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities for participants to join this research endeavor?
"Affirmative, the information hosted on clinicaltrials.gov verifies that this medical experiment is currently enlisting participants. It was first posted in November of 2020 and modified last October of 2022; 63 volunteers are needed across 3 sites for successful completion."
Is this an innovative clinical trial?
"Since the year 2005, AstraZeneca has been investigating Ceralasertib through clinical trials. This drug was granted Phase 1 approval after its inaugural study in 2005 which consisted of 98 participants. Currently, there are 199 active research studies for this medicine being conducted across 1472 towns and 59 nations around the world."
Could I potentially participate in this clinical research?
"This clinical trial is searching for 63 patients between the ages of 12 and 30 who have been diagnosed with osteosarcoma. Individuals must meet certain prerequisites, including having a weight above 40 kgs, an estimated life expectancy over 16 weeks, and performance ratings as specified in Appendix B within 28 days prior to enrollment (excluding any decline seen in the preceding two-week period). Additionally, those that had orthopedic surgery related to their osteosarcoma should not be considered non-ambulatory if such state was caused by said procedure. Finally, all applicants need to have active disease which has either relapsed or failed to"
How many participants are taking part in the experiment?
"AstraZeneca is seeking 63 eligible participants to join their medical trial, which will be conducted across two separate sites in California and Massachusetts. Specifically, UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology in San Francisco and Dana Farber Cancer Institite located in Boston are the predetermined locations for this study."
What objectives are hoped to be achieved through this clinical research?
"This clinical trial has two primary objectives: Cohort 1 Event Free at 4 months and the Number of Participants With Treatment-Related Adverse Events. Secondary outcomes include Event Free Survival, Cohort 2 Event Free Survival 12 months and more. Data will be evaluated over a period of four months after beginning treatment protocol."
What primary applications is Ceralasertib typically associated with?
"Ceralasertib is a commonly used treatment for advance directives. Additionally, it can be utilized to manage malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations that are somatic in nature."
Could you outline the previous research conducted on Ceralasertib?
"Currently, 199 research projects are being conducted that examine the efficacy of Ceralasertib. Of those trials, 27 have progressed to Phase 3 and primarily based in Houston, TX; however, there are over 9400 locations around the world running clinical trials for this treatment."
What known adverse effects are associated with Ceralasertib usage?
"Available data suggests that Ceralasertib has a rating of 2 on the safety scale, as Phase 2 trials have provided evidence for its security but none to assess its efficacy."
Are geriatric patients being admitted to this experiment?
"This clinical trial only allows the enrollment of participants aged between 12 and 30."
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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