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PARP Inhibitor

Olaparib for Cancer

Q: Has Olaparib been granted official sanction by the Food and Drug Administration?

The safety profile of Olaparib is rated a 2 on our scale, since this Phase 2 trial has evidence of safety but no data yet verifying its efficacy.

Q: Is the age cutoff for this research project restricted to those below 40 years of age?

The present investigation is accepting individuals aged between one and twenty-one years old.

Q: How many participants are engaging in this research program?

This trial has since closed recruiting, with its initial post on July 24th 2017 and latest update being October 18th 2022. Fortunately, there are still 5674 clinical trials for rhabdoid tumor looking to admit patients and 188 studies pertaining to Olaparib in search of subjects.

Q: Is this clinical trial currently accepting volunteers?

This trial is no longer open for enrollment, with the study first posted on July 24th 2017 and last updated October 18th 2022. For those seeking alternatives, there are currently 5674 trials looking to recruit participants dealing with rhabdoid tumors and 188 studies actively recruiting patients who require Olaparib treatment.

Q: How many facilities in Canada are currently conducting this investigation?

This clinical trial has 100 spots available at various medical centres, including Carolinas Medical Center/Levine <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute in Charlotte, Sanford USD Medical Center - Sioux Falls in Sioux Falls and Saint Jude Children's Research Hospital in Memphis. Additionally, there are a plethora of other sites providing slots for this study.

Q: Is this a pioneering clinical trial?

Currently, 188 trials involving Olaparib are active across 1468 cities and 59 countries. This medication's journey began in 2005 with a Phase 1 trial sponsored by AstraZeneca; this study enrolled 98 patients and was finished successfully. As of now, 63 studies have been concluded since the initial experiment 15 years ago.

Q: Has Olaparib been subject to previous research?

Olaparib was initially tested in 2005 at Research Site. Since then, 63 investigations have been concluded, with 188 currently ongoing trials largely located near Charlotte, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>.

Q: What is the typical application of Olaparib?

Olaparib is an efficacious remedy for advanced cases and has been known to ease the symptoms of malignancies in ovaries, primary peritoneal <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, phantom sensations, and physical manifestations.

Q: Are there specific criteria that must be met in order to participate in this medical experiment?

For qualification, applicants must have a rhabdoid tumor and be between 12 months to 21 years of age. Additionally, they need to possess radiographically measurable disease at the time of enrolment or an iobenguane (MIBG) positive (+) evaluable illness for <a href="https://www.withpower.com/clinical-trials/neuroblastoma">neuroblastoma</a> sufferers. Other criteria include malignant fluid collections (e.g., ascites, pleural effusions), bone marrow infiltration except that detected by MIBG scan for neuroblastoma and lesions only detectable on nuclear medicine studies such as gallium scans and PET scans). The participants’ body surface area should also exceed 0.65 m

Phase 2

Waitlist Available

Led By Julia Glade-Bender

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

Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131iodine [I]-MIBG)

Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initiation of protocol treatment to the occurrence of disease progression, disease recurrence, or death from any cause, assessed up to 5 years

Awards & highlights

Study Summary

This trial is testing how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in DNA damage repair genes.

Who is the study for?

This trial is for children and young adults aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have relapsed or are refractory. Participants must have a specific gene defect in DNA repair, measurable disease (or MIBG positive neuroblastoma), no prior treatment with PARP inhibitors like olaparib, and meet certain health criteria including kidney function and recovery from previous treatments.Check my eligibility

What is being tested?

The trial tests the effectiveness of Olaparib, a targeted therapy known as a PARP inhibitor. It's designed for patients whose cancer has genetic defects in repairing DNA damage. The drug aims to prevent cancer cells from fixing their damaged DNA, potentially causing them to die off.See study design

What are the potential side effects?

Olaparib may cause side effects such as nausea, vomiting, fatigue, anemia (low red blood cell counts), neutropenia (low white blood cell counts), which can increase infection risk; thrombocytopenia (low platelet counts); diarrhea; indigestion; headache; changes in taste; cough or shortness of breath.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have received radiopharmaceutical therapy.

Select...

I am between 12 and 21 years old.

Select...

I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation.

Select...

I am mostly able to care for myself, regardless of my age.

Select...

I have received external beam radiation therapy.

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My white blood cell count is healthy for cancer treatment.

Select...

I have received a stem cell infusion, with or without total body irradiation.

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My body surface area is at least 0.65 square meters.

Select...

I have never taken PARP inhibitors like olaparib or rucaparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of protocol treatment to the occurrence of disease progression, disease recurrence, or death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of protocol treatment to the occurrence of disease progression, disease recurrence, or death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of protocol treatment to the occurrence of disease progression, disease recurrence, or death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (complete response/partial response)

Secondary outcome measures

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Pharmacokinetics (PK) of olaparib

Progression free survival (PFS)

Other outcome measures

Change in tumor genomic profile

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

Aspartate aminotransferase increased

Dizziness

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib)Experimental Treatment1 Intervention

Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2140

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,147 Total Patients Enrolled

35 Trials studying Rhabdoid Tumor

13,885 Patients Enrolled for Rhabdoid Tumor

Julia Glade-BenderPrincipal InvestigatorChildren's Oncology Group

2 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03233204 — Phase 2

Rhabdoid Tumor Research Study Groups: Treatment (olaparib)

Rhabdoid Tumor Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03233204 — Phase 2

Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03233204 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Olaparib been granted official sanction by the Food and Drug Administration?

"The safety profile of Olaparib is rated a 2 on our scale, since this Phase 2 trial has evidence of safety but no data yet verifying its efficacy."

Answered by AI

Is the age cutoff for this research project restricted to those below 40 years of age?

"The present investigation is accepting individuals aged between one and twenty-one years old."

Answered by AI

How many participants are engaging in this research program?

"This trial has since closed recruiting, with its initial post on July 24th 2017 and latest update being October 18th 2022. Fortunately, there are still 5674 clinical trials for rhabdoid tumor looking to admit patients and 188 studies pertaining to Olaparib in search of subjects."

Answered by AI

Is this clinical trial currently accepting volunteers?

"This trial is no longer open for enrollment, with the study first posted on July 24th 2017 and last updated October 18th 2022. For those seeking alternatives, there are currently 5674 trials looking to recruit participants dealing with rhabdoid tumors and 188 studies actively recruiting patients who require Olaparib treatment."

Answered by AI

How many facilities in Canada are currently conducting this investigation?

"This clinical trial has 100 spots available at various medical centres, including Carolinas Medical Center/Levine Cancer Institute in Charlotte, Sanford USD Medical Center - Sioux Falls in Sioux Falls and Saint Jude Children's Research Hospital in Memphis. Additionally, there are a plethora of other sites providing slots for this study."

Answered by AI

Is this a pioneering clinical trial?

"Currently, 188 trials involving Olaparib are active across 1468 cities and 59 countries. This medication's journey began in 2005 with a Phase 1 trial sponsored by AstraZeneca; this study enrolled 98 patients and was finished successfully. As of now, 63 studies have been concluded since the initial experiment 15 years ago."

Answered by AI

Has Olaparib been subject to previous research?

"Olaparib was initially tested in 2005 at Research Site. Since then, 63 investigations have been concluded, with 188 currently ongoing trials largely located near Charlotte, North carolina."

Answered by AI

What is the typical application of Olaparib?

"Olaparib is an efficacious remedy for advanced cases and has been known to ease the symptoms of malignancies in ovaries, primary peritoneal cancer, phantom sensations, and physical manifestations."

Answered by AI

Are there specific criteria that must be met in order to participate in this medical experiment?

"For qualification, applicants must have a rhabdoid tumor and be between 12 months to 21 years of age. Additionally, they need to possess radiographically measurable disease at the time of enrolment or an iobenguane (MIBG) positive (+) evaluable illness for neuroblastoma sufferers. Other criteria include malignant fluid collections (e.g., ascites, pleural effusions), bone marrow infiltration except that detected by MIBG scan for neuroblastoma and lesions only detectable on nuclear medicine studies such as gallium scans and PET scans). The participants’ body surface area should also exceed 0.65 m"

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)

2017. "Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03233204.

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