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PARP Inhibitor
Olaparib for Advanced Cancer
Phase 2
Waitlist Available
Led By Patricia M LoRusso
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance estimated using the actual body weight and Cockcroft-Gault equation of >= 51 mL/min
Subjects must be diagnosed with a glioma, cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins; patients must have IDH1 or IDH2 mutation which must be detected in a clinical accredited laboratory using a Food and Drug Administration (FDA)-approved molecular test or a validated deoxyribonucleic acid (DNA)-based assay conducted in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; only specific mutations that lead to a neomorphic phenotype will be eligible for enrollment, and include IDH1: R132V, R132G, R132S, R132L, R132C and R132H; IDH2: R140W, R140L, R140Q, R172W, R172G, R172S, R172M, R172K
Must not have
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
This trial will study how well olaparib works in treating patients with certain types of cancer that have spread and usually cannot be controlled with treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
Adults with advanced glioma, cholangiocarcinoma, or solid tumors that have IDH1/IDH2 mutations and are treatment-resistant can join. They must meet certain health criteria like blood cell counts, organ function tests, agree to use contraception if applicable, and be willing to undergo biopsies. Those with recent major surgery, uncontrolled medical issues, HIV/hepatitis or a history of other cancers may not qualify.
What is being tested?
The trial is testing Olaparib's effectiveness on patients whose cancer has spread and doesn't respond to standard treatments. It involves taking the drug orally and monitoring its impact through various assessments including biopsies and imaging techniques like CT scans and MRIs.
What are the potential side effects?
Olaparib could potentially cause side effects such as nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Some might experience changes in taste or mild skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough, based on a specific test.
Select...
My tumor has an IDH1 or IDH2 mutation and has not responded to standard treatments.
Select...
My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.
Select...
My MRI shows my brain tumor is growing.
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I am mostly self-sufficient and can carry out daily activities.
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I have never taken the study drug or any PARP inhibitors before.
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My cancer's progress can be measured by specific medical criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I do not have any serious, uncontrolled health issues or infections.
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I have active hepatitis B or C.
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I have had a bone marrow or double cord blood transplant.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I have never been treated with a PARP inhibitor like olaparib.
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My heart's electrical activity or my family has a history of abnormal rhythms.
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I am not taking any strong or moderate drugs that affect liver enzymes.
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I have brain metastases that are causing symptoms and are not under control.
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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.
Select...
I am not taking strong or moderate CYP3A inhibitor medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Secondary study objectives
Incidence of adverse events
Progression-free survival
Other study objectives
Plasma
2HG plasma magnetic resonance spectroscopy levels
Dysgeusia
Side 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: Treatment (olaparib)Experimental Treatment5 Interventions
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2740
Olaparib
2007
Completed Phase 4
~2190
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,855 Total Patients Enrolled
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
197 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys are functioning well enough, based on a specific test.I am willing and able to follow the study's treatment plan and attend all visits.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I do not have any serious, uncontrolled health issues or infections.I have active hepatitis B or C.I have had a bone marrow or double cord blood transplant.I cannot swallow pills or have stomach issues affecting medication absorption.My tumor has an IDH1 or IDH2 mutation and has not responded to standard treatments.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.I have never been treated with a PARP inhibitor like olaparib.I have not had a blood transfusion in the last 4 months.I understand this trial and can consent, or have someone who can consent for me.I have not had any other cancer in the last 5 years, except for certain types.My heart's electrical activity or my family has a history of abnormal rhythms.I am not taking any strong or moderate drugs that affect liver enzymes.I have brain metastases that are causing symptoms and are not under control.My glioma has come back or gotten worse, and I haven't had surgery or radiation in the last 3 weeks.I haven't had radiation therapy in the last 3 weeks.I am mostly self-sufficient and can carry out daily activities.I have never taken the study drug or any PARP inhibitors before.I am using or will use effective birth control during and for 1 month after the study.I am a man who will use two effective birth control methods during and 3 months after the study.My MRI shows my brain tumor is growing.My cancer is getting worse, and I haven't had certain treatments for at least 30 days.I had major surgery more than 2 weeks ago and have mostly recovered.My high-grade brain tumor has worsened within 12 weeks after finishing chemoradiotherapy.I have a tumor outside the brain that can be measured or tracked over time.My high-grade brain tumor has worsened 12 weeks after finishing treatment.My tumor can be easily biopsied, and I agree to multiple biopsies.My side effects from past cancer treatments are mild, except for hair loss or stable long-term effects.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I am 18 years old or older.I am not taking strong or moderate CYP3A inhibitor medications.My cancer's progress can be measured by specific medical criteria.My WHO grade II glioma has progressed according to specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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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