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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
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer has spread to other parts of my body.
Select...
I have been treated with anthracycline and taxane for my cancer.
Select...
My cancer can be measured by standard imaging techniques.
Select...
My cancer has specific genetic changes related to how cells repair DNA.
Select...
I have a harmful BRCA1 or BRCA2 mutation but not in my germline.
Select...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 53 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 months
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 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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
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
3,950 Previous Clinical Trials
5,174,593 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,419 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,189 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MDS, AML, or conditions that suggest I might have them.My advanced cancer has no cure and standard treatments have failed.My breast cancer is due to a BRCA mutation.I am fully active or restricted in physically strenuous activity but can do light work.You are allergic to the ingredients in olaparib.I have an active hepatitis infection.My cancer is not breast or ovarian but has BRCA mutations, or it lacks BRCA and homologous recombination repair mutations.I have not taken any colony-stimulating factors in the last 28 days.My breast cancer has spread to other parts of my body.I am using or willing to use effective birth control or practice abstinence, and will not breastfeed during the study.I had radiotherapy over 2 weeks ago, have no side effects, and don't need steroids.I have had a bone marrow or cord blood transplant.I have been treated with olaparib or another PARP inhibitor before.I have been diagnosed with HIV.I have been treated with anthracycline and taxane for my cancer.I am a male and agree to use contraception and not donate sperm for 3 months and 5 days after my last treatment dose.I am not pregnant or breastfeeding.My cancer can be measured by standard imaging techniques.My cancer is hormone receptor-positive and has not responded to at least one hormone therapy.I have brain metastases but have been stable and off steroids for 14 days.My cancer has specific genetic changes related to how cells repair DNA.My cancer did not worsen while I was on platinum-based chemotherapy or within 4 weeks after finishing it.I have another cancer besides skin or early-stage cervical cancer that needed treatment in the last 5 years.I have not had a whole blood transfusion in the last 120 days.I have a harmful BRCA1 or BRCA2 mutation but not in my germline.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I haven't had cancer treatment like chemotherapy or hormone therapy in the last 3 weeks.I can provide a recent biopsy or an older tissue sample of my tumor.My primary cancer source is unknown.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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