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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
Negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on cycle 1 day 1 and during the study for child bearing potential women
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post treatment
Awards & highlights

Study 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 below
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I have taken a pregnancy test that was negative before starting the study treatment.
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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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My liver function tests are within normal limits, unless I have liver metastases.
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I am fully active or can carry out light work.
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I was treated with a PARP inhibitor for 4 months or more before my disease progressed.
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I am willing and able to follow the study's treatment plan and attend all visits.
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My white blood cell count is healthy without recent medication to boost it.
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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.

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

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 • 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%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
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

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
~2140

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,721 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,105 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04090567 — Phase 2
Breast Cancer Research Study Groups: Arm II (olaparib plus ceralasertib), Arm I (olaparib plus cediranib)
Breast Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are more participants needed for this experiment at the present time?

"Indeed, clinicaltrials.gov reveals that this medical experiment is actively accepting participants. It was initially posted on July 28th 2020 and updated as recently as March 31st 2022. Approximately 60 individuals are expected to be recruited from a single site."

Answered by AI

What is the current capacity for enrolment in this research project?

"Indeed, the clinical trial data present on clinicialtrials.gov confirms that recruitment for this study is still ongoing. It was initially posted on July 28th 2020 and most recently updated in March 31st 2022, with a need to recruit 60 patients from 1 medical centre."

Answered by AI

To what degree can Olaparib be considered a risk to human health?

"As this is a second-phase trial, there's evidence of Olaparib's safety making its score 2 out of 3. However, no data exists to support the drug's efficacy yet."

Answered by AI

Could you elaborate on any additional research done with Olaparib?

"Olaparib is the subject of 204 active research trials, 27 which are in their final phase. While Houston, Texas houses many studies for this drug, there are over 9 thousand other locations running clinical trials on its efficacy."

Answered by AI

Is this experiment the inaugural endeavor of its kind?

"Globally, there are 204 dynamic clinical trials involving the drug Olaparib being conducted across 59 countries and 1490 cities. The original trial for this medication began in 2005 when 98 participants took part in a Phase 1 Drug Approval study sponsored by AstraZeneca. Since then, 113 studies have been concluded."

Answered by AI

What ailments is Olaparib typically prescribed to treat?

"Olaparib is a medication that can be prescribed to treat numerous conditions, ranging from advanced directives to malignant neoplasm of ovary and primary peritoneal cancer. It may also be administered for hallucinations and somatic problems."

Answered by AI
~12 spots leftby Mar 2025