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Monoclonal Antibodies
Cediranib + Olaparib vs Bevacizumab for Recurrent Glioblastoma
Phase 2
Waitlist Available
Led By Isabel Arrillaga-Romany
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Only first and second recurrences of GBM are eligible
Creatinine should not exceed the institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is comparing the effectiveness of cediranib maleate and olaparib vs bevacizumab in treating patients with recurrent glioblastoma.
Who is the study for?
This trial is for adults with recurrent glioblastoma who've had prior radiotherapy and temozolomide treatment. Eligible participants must have stable or decreasing corticosteroid doses, adequate organ function, no severe allergies to the drugs being tested, and not be pregnant or breastfeeding. They should agree to use contraception and have a life expectancy of at least 3 months.Check my eligibility
What is being tested?
The study compares cediranib maleate plus olaparib against bevacizumab in treating recurrent glioblastoma. Cediranib maleate and olaparib are thought to block enzymes needed for tumor growth, while bevacizumab is an immunotherapy that may inhibit cancer spread.See study design
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, risk of bleeding or clotting issues due to blood vessel effects from cediranib/bevacizumab; nausea; diarrhea; low blood counts leading to infection risk; allergic reactions; possible harm to unborn babies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My GBM has recurred no more than twice.
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My kidney function tests are within normal range.
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My corticosteroid dose has been stable or decreasing for the last 5 days.
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My brain scans show my tumor is growing, or I have a confirmed recurrent glioblastoma.
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I can care for myself but may need occasional help.
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My hemoglobin is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.
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All my side effects from previous treatments are gone, except maybe for hair loss.
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I have been treated with radiotherapy and temozolomide before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Progression-Free Survival at 6 Months
Secondary outcome measures
Imaging Correlates (Vascular Permeability, Tumor Perfusion and Oxygenation, Brain Tumor Cellularity)
Incidence of Adverse Events (AE)
Levels of Circulating Cytokines Involved With Angiogenesis
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (bevacizumab)Experimental Treatment1 Intervention
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (olaparib, cediranib maleate)Experimental Treatment3 Interventions
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Cediranib
2016
Completed Phase 3
~4030
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,294 Total Patients Enrolled
324 Trials studying Glioblastoma
23,102 Patients Enrolled for Glioblastoma
Isabel Arrillaga-RomanyPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an abdominal abscess in the last 6 months.I have never had pneumonitis.My GBM has recurred no more than twice.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have never had a hypertensive crisis or brain issues due to high blood pressure.I have early-stage breast or cervical cancer.I have unstable chest pain.I do not have any serious illnesses that are not under control.I have not used PARP inhibitors or drugs affecting the VEGF pathway.It's been over 12 weeks since my last radiotherapy, or my cancer has grown outside the treated area if it's been less.You are expected to live for at least 3 more months.I have serious blood vessel problems in my arms or legs.My heart's electrical activity is normal and I have no family history of long QT syndrome.I am not pregnant, not breastfeeding, and willing to use birth control during the study.I have moderate to severe heart failure.My blood pressure is controlled and I take 3 or fewer medications for it.I have not had any abdominal openings or gut tears in the last 6 months.I have a serious blood vessel condition like an aortic aneurysm.My heart's pumping ability is normal or above 55%.I am not pregnant or breastfeeding.I am willing to provide my previous biopsy samples for research.My kidney function tests are within normal range.I haven't had major surgery or significant injury in the last 28 days and don't expect to need any during the study.I am not taking strong or moderate CYP3A4 inhibitors or inducers.My corticosteroid dose has been stable or decreasing for the last 5 days.I have no other cancers besides the one being treated.My brain scans show my tumor is growing, or I have a confirmed recurrent glioblastoma.I can care for myself but may need occasional help.I have had a stroke in the last 6 months.My hemoglobin is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.I had a heart attack in the last six months.I have waited the required time after my last cancer treatment to start a new one.I had cancer before, treated to cure, with no signs of it coming back for 3 years.All my side effects from previous treatments are gone, except maybe for hair loss.I have been treated with radiotherapy and temozolomide before.You cannot be taking any other experimental drugs or treatments.I haven't had symptoms of bowel obstruction in the last 3 months.You have had allergic reactions to medications similar to olaparib, cediranib, or bevacizumab in the past.People who have any of the following:I have been treated for early-stage skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (olaparib, cediranib maleate)
- Group 2: Arm B (bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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