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PARP Inhibitor
Olaparib + Cediranib/Ceralasertib for Advanced Breast Cancer
Phase 2
Recruiting
Led By Banu Arun
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry and be using highly effective contraception
Patients must have creatinine clearance estimated using the Cockcroft-Gault creatinine clearance equation of >= 51 mL/min, and a random or 24 hours urine protein creatinine (UPC) ratio =< 1
Must not have
Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
Any of the following cardiac criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post treatment
Awards & highlights
Summary
This trial studies olaparib with cediranib or AZD6738 as a treatment for patients with BRCA mutated breast cancer that has spread to other places in the body.
Who is the study for?
This trial is for women with advanced or metastatic breast cancer that has a BRCA mutation. They must have previously responded to PARP inhibitor treatment for at least 4 months, have good organ function, and controlled blood pressure. Pregnant or breastfeeding women can't join, nor those who've had certain treatments recently or have conditions affecting drug absorption.Check my eligibility
What is being tested?
The study tests how well olaparib works with either cediranib or AZD6738 in treating BRCA mutated breast cancer that's spread. It aims to see if these combinations can block enzymes needed for tumor growth more effectively than current treatments.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk, high blood pressure, shortness of breath, and possible allergic reactions. Some patients may experience issues related to liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and use effective birth control or cannot become pregnant.
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My kidney function is good, based on tests.
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I am fully active or can carry out light work.
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My thyroid function is normal, with no symptoms of issues.
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My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.
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I can take pills and don’t have stomach issues affecting medicine absorption.
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I am willing to have a biopsy of my cancer that has spread.
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My breast cancer is advanced, HER2 negative, BRCA positive, and has not responded to hormone therapy.
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My blood pressure is under control with up to 3 medications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a bone marrow or double cord blood transplant.
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My heart health meets the study's requirements.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I have serious blood vessel problems.
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I do not have ataxia telangiectasia.
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I have seizures that are not controlled by medication.
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I have previously been treated with AZD 6738 and cediranib.
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I am currently using herbal products or alternative medicines.
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I had major surgery over 3 weeks ago and have recovered from it.
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I am receiving treatment for congestive heart failure.
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I haven't had chemotherapy or radiation in the last 3 weeks and have no major side effects from past cancer treatments.
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I am not taking any strong medication that affects liver enzymes.
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I have brain metastases or spinal issues related to my cancer that haven't been treated.
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I am allergic to medications similar to cediranib, olaparib, or AZD6738.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have previously been treated with a VEGF inhibitor.
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I have not had any other cancer besides this one in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Secondary outcome measures
Duration of response (DOR)
Progression free survival (PFS)
Other outcome measures
Biomarker analysis
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (olaparib plus ceralasertib)Experimental Treatment2 Interventions
Patients receive olaparib PO BID on days 1-28 and ceralasertib PO QD on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (olaparib plus cediranib)Experimental Treatment2 Interventions
Patients receive olaparib PO BID and cediranib PO 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
Ceralasertib
2017
Completed Phase 1
~30
Cediranib
2016
Completed Phase 3
~4030
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,219 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,341 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Banu ArunPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
656 Total Patients Enrolled
1 Trials studying Breast Cancer
66 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had symptoms of bowel blockage in the last 3 months.I do not have any bleeding disorders.I have taken a pregnancy test that was negative before starting the study treatment.I am not pregnant and use effective birth control or cannot become pregnant.I have had a bone marrow or double cord blood transplant.My kidney function is good, based on tests.My heart health meets the study's requirements.My liver function tests are within normal limits, unless I have liver metastases.I cannot swallow pills or have stomach issues affecting medication absorption.I have serious blood vessel problems.I do not have ataxia telangiectasia.I have seizures that are not controlled by medication.I am fully active or can carry out light work.I have previously been treated with AZD 6738 and cediranib.You have a hole in a specific area of your lung.I am currently using herbal products or alternative medicines.My tests may show signs of MDS or AML.Your bilirubin levels must be within a certain range as determined by the hospital.Your platelet count is at least 100 billion per liter.I had major surgery over 3 weeks ago and have recovered from it.I have not had major surgery or significant injury within the last 28 days.I was treated with a PARP inhibitor for 4 months or more before my disease progressed.The amount of protein in your urine is very low.I am receiving treatment for congestive heart failure.I am willing and able to follow the study's treatment plan and attend all visits.My white blood cell count is healthy without recent medication to boost it.My thyroid function is normal, with no symptoms of issues.I have not had significant bleeding or coughed up blood in the last month.I had a heart attack, stroke, or mini-stroke in the last 6 to 12 months.I haven't had chemotherapy or radiation in the last 3 weeks and have no major side effects from past cancer treatments.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.My cancer returned or worsened within 1 month after finishing platinum-based chemotherapy for advanced cancer.I am not taking any strong medication that affects liver enzymes.I have brain metastases or spinal issues related to my cancer that haven't been treated.I am allergic to medications similar to cediranib, olaparib, or AZD6738.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have a tumor that can be measured using specific guidelines.I have previously been treated with a VEGF inhibitor.I do not have severe diseases, uncontrolled bleeding, kidney transplant, or active infections like hepatitis or HIV.I have not had an abdominal abscess in the last 3 months.I can take pills and don’t have stomach issues affecting medicine absorption.I am willing to have a biopsy of my cancer that has spread.My breast cancer is advanced, HER2 negative, BRCA positive, and has not responded to hormone therapy.I have not had any other cancer besides this one in the last 5 years.My blood pressure is under control with up to 3 medications.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (olaparib plus ceralasertib)
- Group 2: Arm I (olaparib plus cediranib)
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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