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PARP Inhibitor

Olaparib for Solid Tumors

Phase 2

Recruiting

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

ANC >= 1.5 x 10^9/L

No previous treatment with the specific assigned study drug or any other PARP inhibitor

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 1 year

Awards & highlights

No Placebo-Only Group

Study 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.

Eligible Conditions

Cancer
Glioblastoma
Cholangiocarcinoma
Solid Tumors
Low Grade Glioma
Gliomas
Brain Tumor

Eligibility Criteria

Inclusion Criteria

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

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You are expected to live for at least 16 weeks.

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Your tumor must be easy to reach for biopsy, and you must be willing to undergo multiple biopsies.

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If you have cancerous growths outside of your brain, there must be at least one that can be easily measured or examined.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall response rate

Secondary outcome measures

Incidence of adverse events

Progression-free survival

Other outcome measures

Plasma

2HG plasma magnetic resonance spectroscopy levels

Dysgeusia

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%

Dyspnoea

11%

Alanine aminotransferase increased

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Neuropathy peripheral

10%

Pruritus

Thrombocytopenia

Dizziness

Hyperglycaemia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Aspartate aminotransferase increased

Blood creatinine increased

Weight decreased

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Dysgeusia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

General physical health deterioration

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Bladder papilloma

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

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: 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

Biopsy

2014

Completed Phase 4

~1160

Biospecimen Collection

2004

Completed Phase 1

~1540

Computed Tomography

2017

Completed Phase 2

~2890

Magnetic Resonance Imaging

2017

Completed Phase 3

~1250

Olaparib

2017

Completed Phase 4

~1270

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,489 Previous Clinical Trials

41,266,536 Total Patients Enrolled

Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO

5 Previous Clinical Trials

197 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03212274 — Phase 2

Cancer Research Study Groups: Treatment (olaparib)

Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03212274 — Phase 2

Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03212274 — Phase 2

Frequently Asked Questions

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

What supplementary investigations have been performed utilizing Olaparib?

"Olaparib first underwent clinical trials in 2005 at Research Site, with 63 studies having been completed since. Currently, 188 active trials are being carried out across the United States of America - many of which originated from Overland Park, Kansas."

Answered by AI

How many subjects are being included in this medical research?

"In order to complete the study, 145 eligible participants are needed. The research will take place at two University of Kansas locations: Hospital-Indian Creek Campus in Overland Park and Westwood Cancer f Kansas locations: Hospital-Indian Creek Campus in Overland Park and Westwood Cancer Center in Westwood."

Answered by AI

Is this experiment pathbreaking in its approach?

"Olaparib has been under clinical study since 2005, with the first trial sponsored by AstraZeneca. After its Phase 1 approval in 2005 following a 98-patient sample size evaluation, there are presently 188 ongoing trials of Olaparib spread over 1468 cities and 59 countries worldwide."

Answered by AI

In what quantity of medical establishments is this experiment being conducted?

"This clinical trial is currently being offered from 34 different sites, including Overland Park, Westwood and Nashville. To reduce the need for long-distance travel during your participation in this study, we recommend selecting a site close to you."

Answered by AI

Are new participants being enrolled in this medical experiment?

"Affirmative. According to the clinical trials website, this medical experiment is currently recruiting participants. Initially posted on March 30th 2018 and most recently updated October 18th 2022, 145 patients are needed from 34 sites across the country."

Answered by AI

To what extent can patients rely on Olaparib to be secure?

"The safety rating for Olaparib was 2, as the Phase 2 trial has yet to produce any evidence of efficacy. This score is based on existing data that points towards its safety."

Answered by AI

What pathologies can be ameliorated through the utilization of Olaparib?

"Olaparib is used to treat a range of maladies, including advance directives and the cancerous growths in the ovary or peritoneum. Additionally, it can be effective against hallucinations, somatic."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

2019. "Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03212274.

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