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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer (all patients) suitable for central HRR testing and a blood sample (patients ≥2 years old) for central germline BRCA testing must be provided for each patient
For all non-neuroblastoma tumours, patients must have at least 1 radiographical assessable lesion (measurable and/or non-measurable). For neuroblastoma tumours, patients must have radiographical assessable disease with at least 1 lesion (measurable and/or non measurable) OR disease evidenced by uptake of meta-iodobenzylguanidine- (MIBG) or fluorodeoxyglucose positron emission tomography (FDG-PET) scans
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 64 months
Awards & highlights
Study Summary
This trial is testing the safety of a drug called olaparib in children and adolescents with solid tumors.
Who is the study for?
This trial is for children and adolescents aged 6 months to under 18 with solid tumors that have relapsed or are resistant to treatment. They must be able to swallow tablets, have a tumor sample available for testing, and meet specific genetic criteria indicating a deficiency in HRR (a DNA repair process). Patients who've had certain recent treatments or those with blood disorders like MDS/AML can't participate.Check my eligibility
What is being tested?
The study tests the safety and tolerability of Olaparib, a medication targeting cancer cells' DNA repair mechanisms. It's given to young patients with solid tumors. The trial has two phases: dose finding for all eligible patients and signal identification specifically for those with confirmed HRR gene mutations.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Olaparib may include nausea, fatigue, anemia (low red blood cell counts), vomiting, diarrhea, decreased appetite, headache, coughing and shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tumor sample and, if I'm over 2, a blood sample for testing.
Select...
My cancer can be seen and measured on scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 64 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 64 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity [DLTs]
Safety profile
Secondary outcome measures
Apparent total clearance of the drug from plasma at steady state after oral administration [CLss/F]
Area under the curve at 0-8 hours [AUC(0-8)]
Area under the curve at steady state [AUCss]
+9 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%
Hyperglycaemia
9%
Aspartate aminotransferase increased
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
4Treatment groups
Experimental Treatment
Group I: Signal identificationExperimental Treatment1 Intervention
A secondary analysis of response in patients recruited into the signal identification phase will be conducted. Patients included in this analysis must have documented evidence of a deleterious or suspected deleterious germline or tumour HRR gene mutation. A minimum of 10 patients across age and dose cohorts with deleterious or suspected deleterious HRR mutations will be enrolled.
Group II: Cohort C: ≥6 months to <6 yearsExperimental Treatment1 Intervention
Patients will receive a single dose of olaparib on Day 1, followed by initiation of bd continuous dosing from Day 2 onwards. Olaparib should be taken at the same time each day (morning and evening), approximately 12 hours apart. Patients in Cohort C will receive a predetermined number of each sprinkle capsule strength (15 and 19.5 mg,) to make up the required dose. Olaparib sprinkle capsules will be administered to the child by the parent/caregiver. Patients in Cohort C are not required to fast including PK sampling days. The dispensed granules should be swallowed whole and not chewed, crushed, dissolved or divided, and should be consumed within 30 minutes of preparation.
Group III: Cohort B: ≥3 to <12 yearsExperimental Treatment1 Intervention
Patients will receive a single dose of olaparib on Day 1, followed by initiation of bd continuous dosing from Day 2 onwards. Olaparib tablets should be taken at the same time each day (morning and evening), approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food, with the exception of Day 8 (a PK sampling day) when patients aged ≥3 years old receiving tablets should take olaparib at least 1 hour after food and should refrain from eating for up to 2 hours afterwards.
Group IV: Cohort A: ≥12 to <18 yearsExperimental Treatment1 Intervention
Patients will receive a single dose of olaparib on Day 1, followed by initiation of bd continuous dosing from Day 2 onwards. Olaparib tablets should be taken at the same time each day (morning and evening), approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food, with the exception of Day 8 (a PK sampling day) when patients aged ≥3 years old receiving tablets should take olaparib at least 1 hour after food and should refrain from eating for up to 2 hours afterwards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,613,330 Total Patients Enrolled
Milenkova TsvetaStudy DirectorAstraZeneca
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any strong or moderate drugs that affect enzyme CYP3A.My cancer has returned or is not responding to treatment, and it lacks certain repair genes.I have been treated with a PARP inhibitor like olaparib before.I am between 6 months and 18 years old.I can provide a tumor sample and, if I'm over 2, a blood sample for testing.My overall health is good enough for tests and treatment.I haven't had cancer radiotherapy (except for comfort care) or any approved cancer drugs in the last 30 days.I have not had a whole blood transfusion in the last 4 months.My cancer can be seen and measured on scans.I have been diagnosed with MDS/AML or have symptoms suggesting it.I cannot swallow pills.I still have side effects from past cancer treatments.I do not have untreated brain or spinal issues related to my cancer.I can swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: ≥12 to <18 years
- Group 2: Cohort B: ≥3 to <12 years
- Group 3: Cohort C: ≥6 months to <6 years
- Group 4: Signal identification
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research original or has it already been conducted?
"Olaparib has had a long history of clinical trials, with the first study taking place in 2005. Sponsored by AstraZeneca, this original trial involved 98 patients and led to Phase 1 drug approval. Currently, 59 countries around the world host 188 active studies on Olaparib across 1468 cities."
Answered by AI
Is there any eligibility criteria preventing me from partaking in this research?
"Individuals aged 0-18, who possess solid tumors are eligible to apply for this trial. There is a maximum of 30 participants that will be accepted in total."
Answered by AI
How many participants have committed to this research project?
"Affirmative, the data from clinicaltrials.gov states that recruiting is underway for this trial which was initially uploaded on January 14th 2020 and last reviewed November 7th 2022. This research requires 30 subjects to be enrolled across two sites."
Answered by AI
What are the expected results of this research?
"Over a period of 28 days, the primary observed outcome of this trial will be safety. Secondary outcomes include Area under the Curve at Steady State levels in mcg/mL, as well as Objective Response Rate based on International Neuroblastoma Response Criteria, RECIST and RANO standards."
Answered by AI
Has Olaparib been granted permission for sale by the Food and Drug Administration?
"There is limited data on the efficacy and safety of Olaparib, which earned it a score of 1."
Answered by AI
Are there any other research investigations which have employed Olaparib?
"Olaparib was first tested in research labs back in 2005. Presently, there have been 63 clinical trials completed and 188 active studies taking place; many of them located within the province of Quebec, Montreal."
Answered by AI
What is the principal therapeutic application of Olaparib?
"Olaparib is frequently prescribed for the treatment of advance directives, but it can also be employed to handle malignant neoplasm of ovary, primary peritoneal cancer, and somatic hallucinations."
Answered by AI
Is the upper age limit for recruitment of this trial below sixty years?
"This clinical trial can only accept minors between 0 and 18 years old. Presently, there are 329 trials for youths and 2573 trails designed for the elderly population."
Answered by AI
Are any participants being enrolled into this experiment at the moment?
"This research is currently looking for participants; the trial went live on January 14th 2020 and was amended as of November 7th 2022, per clinicaltrials.gov."
Answered by AI
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