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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 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

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

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

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