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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
No Placebo-Only Group

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.
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.
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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate
Secondary study objectives
Duration of response (DOR)
Progression free survival (PFS)
Other study objectives
Biomarker analysis

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
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%
Dizziness
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~40
Cediranib
2016
Completed Phase 3
~4030
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,549 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,000 Total Patients Enrolled
1 Trials studying BRCA2 Mutation
18 Patients Enrolled for BRCA2 Mutation
Banu ArunPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
656 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04090567 — Phase 2
BRCA2 Mutation Research Study Groups: Arm II (olaparib plus ceralasertib), Arm I (olaparib plus cediranib)
BRCA2 Mutation Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04090567 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090567 — Phase 2
~4 spots leftby Mar 2025