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PARP Inhibitor

Olaparib for Advanced Cancer

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
- Has histologically- or cytologically-confirmed breast cancer with evidence of metastatic disease.
Must not have
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has known active hepatitis infection (i.e., Hepatitis B or C).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study a new drug to treat cancer that has progressed or been intolerant to standard of care therapy, and is positive for a certain gene mutation.

Who is the study for?
This trial is for adults with advanced cancers that have worsened after standard care or if they're intolerant to it. They must have specific genetic changes (HRRm/HRD positive) and be able to provide a biopsy. Participants need a life expectancy of at least 3 months, good organ function, and an ECOG status of 0 or 1. Men must use contraception; women not pregnant/breastfeeding should also use effective birth control.
What is being tested?
The study tests Olaparib's effectiveness and safety in treating various advanced cancers with certain genetic mutations (HRRm/HRD). Patients previously treated without success are given this medication as monotherapy to see how well it works against their cancer.
What are the potential side effects?
Olaparib may cause side effects like nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, shortness of breath, headache, appetite loss, and taste changes. Some patients might experience more serious issues affecting the lungs or kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer has spread to other parts of my body.
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I have been treated with anthracycline and taxane for my cancer.
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My cancer can be measured by standard imaging techniques.
Select...
My cancer has specific genetic changes related to how cells repair DNA.
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I have a harmful BRCA1 or BRCA2 mutation but not in my germline.
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I can provide a recent biopsy or an older tissue sample of my tumor.

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 MDS, AML, or conditions that suggest I might have them.
Select...
I have an active hepatitis infection.
Select...
I have had a bone marrow or cord blood transplant.
Select...
I have been treated with olaparib or another PARP inhibitor before.
Select...
I have been diagnosed with HIV.
Select...
I cannot take pills by mouth or have a condition that affects how my body absorbs medication.
Select...
My primary cancer source is unknown.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 53 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Duration of Response (DOR)
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
Number of Participants Experiencing an Adverse Event (AE)
+6 more

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

1Treatment groups
Experimental Treatment
Group I: OlaparibExperimental Treatment1 Intervention
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,019 Previous Clinical Trials
5,186,117 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,403 Previous Clinical Trials
289,124,619 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,073 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03742895 — Phase 2
Solid Tumors Research Study Groups: Olaparib
Solid Tumors Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03742895 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03742895 — Phase 2
~82 spots leftby Jun 2026
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