← Back to Search

Olaparib for BRCA Mutations (POLO Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto 4 years

Awards & highlights

POLO Trial Summary

This trial is testing olaparib as a maintenance treatment for metastatic pancreatic cancer in people whose disease has not progressed on first line platinum-based chemotherapy.

Eligible Conditions

BRCA Mutations
Pancreatic Cancer

POLO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 4 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

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)

Secondary outcome measures

Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire

Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1

Number of Participants With Adverse Events (AEs)

+6 more

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

POLO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OlaparibExperimental Treatment1 Intervention

Olaparib tablets po. 300 mg twice daily

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablets twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,549 Total Patients Enrolled

1 Trials studying BRCA Mutations

450 Patients Enrolled for BRCA Mutations

Myriad Genetic Laboratories, Inc.Industry Sponsor

31 Previous Clinical Trials

14,483 Total Patients Enrolled

1 Trials studying BRCA Mutations

450 Patients Enrolled for BRCA Mutations

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,992 Total Patients Enrolled

2 Trials studying BRCA Mutations

473 Patients Enrolled for BRCA Mutations

Frequently Asked Questions

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

What is the most recent news on Olaparib's government regulation?

"Given that this is a Phase 3 trial with available evidence backing up its efficacy as well as its safety from multiple rounds of testing, our team at Power rates Olaparib's safety as a 3."

Answered by AI

Have similar clinical trials been conducted in the past?

"There are 193 ongoing clinical trials worldwide that are testing the efficacy of Olaparib. These trials are located in 59 different countries and 1451 cities. The first trial for Olaparib was completed in 2005. This initial study, which was sponsored by AstraZeneca, included 98 patients and successfully completed Phase 1 drug approval. In the 16 years since 2005, a total of 18305 clinical trials have been completed."

Answered by AI

What are Olaparib's primary therapeutic applications?

"Olaparib is an effective treatment for advance directives, primary peritoneal cancer, and malignant neoplasm of the ovary."

Answered by AI

Are there any current vacancies for study participants?

"According to the latest information found on clinicaltrials.gov, this study is not recruiting patients at this time. Although the trial was most recently updated on September 12th, 2022, it is not currently looking for participants. There are 1468 other trials that are actively recruiting patients right now."

Answered by AI

For which patients is this clinical trial designed?

"The prerequisites for enrolling in this trial are carrying the brca1 gene and being between 18 and 130 years old. So far, the study has recruited 154 individuals."

Answered by AI

What is the projected headcount for this clinical trial?

"Unfortunately, this study is not currently looking for new participants. The first posting was on December 16th, 2014 and the most recent update was on September 12th, 2022. However, there are 1275 other clinical trials that are searching for patients with the brca1 gene and 193 trials for Olaparib that are still admitting patients."

Answered by AI

Are people who are over 45 years old eligible to participate in this trial?

"The age range for people who can participate in this trial are those 18 years old or older, and 130 years old or younger."

Answered by AI

Can you tell me if Olaparib has been studied before?

"First appearing in 2005 at Research Site, olaparib has since been the focus of 18305 clinical studies. As of now, 193 of these trials are actively recruiting patients, with a large concentration in Boca Raton, Florida."

Answered by AI

Where can I find a list of places where this trial is being conducted?

"Enrolling patients from 21 different centres, this study has locations in Boca Raton, Orange, Stanford, and other cities. If you are considering enrolling in the study, it may be beneficial to choose the closest location to you in order to reduce travel time and costs."

Answered by AI