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PARP Inhibitor

Olaparib for Prostate Cancer

Phase 2

Waitlist Available

Led By Catherine H Marshall, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks

Normal organ and bone marrow function measured within 28 days prior to administration of study treatment

Must not have

Myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML

Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial of olaparib shows that it may be effective in treating metastatic castration-resistant prostate cancer, with 11 out of 49 patients responding positively to the drug. However, more research is needed to determine the optimal timing for olaparib therapy and whether it is effective in earlier disease states.

Who is the study for?

Men with high-risk, non-metastatic prostate cancer post-prostatectomy can join this trial. They should have a rapidly rising PSA level, good physical condition (ECOG 0-1), and no prior ADT or strong CYP3A inhibitors in the last 6 months. Participants need normal organ/bone marrow function and agree to use effective contraception.

What is being tested?

The trial is testing Olaparib's effectiveness for prostate cancer at an earlier stage than previously studied. It involves men whose cancer has returned biochemically after surgery but hasn't spread elsewhere, focusing on those with specific genetic mutations linked to DNA repair.

What are the potential side effects?

Olaparib may cause blood-related issues like anemia, nausea, fatigue, digestive problems, shortness of breath, headache, muscle or joint pain. Rarely it could lead to more serious conditions such as blood clots or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent scans show no signs of cancer spread.

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My organ and bone marrow functions are normal as tested within the last 28 days.

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I am a man who will use two effective birth control methods during and 3 months after the study.

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My genetic test shows a harmful mutation in a specific cancer-related gene.

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I am fully active or can carry out light work.

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My cancer is a type of prostate cancer called adenocarcinoma.

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I have had a prostatectomy and can provide tissue samples for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I had major surgery more than 2 weeks ago and have recovered from it.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I do not have active hepatitis B or C.

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I am not currently using strong or moderate drugs that affect liver enzymes.

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I have never been treated with a PARP inhibitor like olaparib.

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I am not currently taking strong or moderate CYP3A inhibitors, or I have completed the required washout period.

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My heart's electrical activity is irregular, or I have a family history of long QT syndrome.

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I have had chemotherapy through an IV before.

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I have a serious health condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer

Secondary study objectives

Duration of Undetectable PSA

PSA Progression-free Survival

Treatment-related Adverse Events as Assessed by CTCAE v4.0

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

Hyperglycaemia

Dizziness

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

1Treatment groups

Experimental Treatment

Group I: Olaparib 300 mg BIDExperimental Treatment1 Intervention

Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

0 / 17Eligibility criteria met