← Back to Search

PARP Inhibitor

olaparib for Breast

Phase 2
Waitlist Available
Led By Bella Kaufman, MD
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 survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
Awards & highlights

Study Summary

This trial will test how well olaparib works in treating patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation.

Eligible Conditions
  • Breast
  • Pancreatic
  • Tumors
  • Ovarian
  • Prostate

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumour Response Rate
Secondary outcome measures
Disease Control Rate at Week 16
Duration of Response
Objective Response Rate
+3 more

Side effects data

From 2023 Phase 3 trial • 387 Patients • NCT02987543
43%
Anaemia
43%
Nausea
30%
Decreased appetite
27%
Fatigue
21%
Diarrhoea
19%
Constipation
19%
Vomiting
14%
Asthenia
14%
Back pain
13%
Oedema peripheral
11%
Cough
10%
Arthralgia
9%
Dyspnoea
8%
Dyspepsia
8%
Weight decreased
7%
Dysgeusia
7%
Thrombocytopenia
7%
Musculoskeletal pain
7%
Dizziness
7%
Urinary tract infection
6%
Headache
6%
Pyrexia
5%
Neutropenia
5%
Musculoskeletal chest pain
5%
Lymphopenia
5%
Insomnia
5%
Stomatitis
5%
Pain in extremity
4%
Pneumonia
2%
Haematuria
2%
Pulmonary embolism
1%
Sepsis
1%
Femur fracture
1%
Hyponatraemia
1%
Muscular weakness
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Cardiopulmonary failure
1%
Urinary retention
1%
Bone pain
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A+B Olaparib 300mg bd
Cohort A+B Investigators Choice of NHA

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
olaparib
2009
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,488 Total Patients Enrolled
1 Trials studying Breast
264 Patients Enrolled for Breast
Jane Robertson, BSc, MBCHB, MDStudy DirectorAstraZeneca
11 Previous Clinical Trials
1,168 Total Patients Enrolled
Bella Kaufman, MDPrincipal InvestigatorChaim Sheba Medical Centre, Tel Hashomer, Israel

Frequently Asked Questions

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

Are there any opportunities for participation in this research endeavor?

"Clinicaltrials.gov displays that this research project, which began on February 21st 2010 and was last updated October 4th 2022, is not seeking participants currently; however there are 195 other medical trials actively recruiting patients at the present time."

Answered by AI

How many participants can join this experiment?

"At this juncture, recruitment for the clinical trial has ceased. The study was first made available on February 21st 2010 and last updated October 4th 2022. If you are looking to participate in further medical studies, 7 trials related to prostate cancer and 188 related to olaparib currently have open enrolment programs."

Answered by AI

Is this a pioneering clinical trial?

"Presently, there are 188 separate clinical investigations of olaparib active in 59 countries and 1468 cities. The first assessment occurred back in 2005 and was sponsored by AstraZeneca; it involved 98 individuals and achieved Phase 1 drug approval status. In the 15 years since then, 63 additional trials have been conducted."

Answered by AI

Has olaparib been given the stamp of approval by the FDA?

"Considering the Phase 2 status of olaparib, which has data to support safety but not yet efficacy, our team at Power assigned it a rating of 2."

Answered by AI

Is the enrollment criterion for this trial restricted to seniors or are younger individuals able to participate?

"This clinical trial is available to adults that are over 18 years old and no more than 130 years of age."

Answered by AI

Could you supply a summary of prior research involving olaparib?

"At present, there are 188 clinical trials actively studying olaparib with 27 of them in the final stage. While Houston is a major hub for these studies, they span 9250 sites throughout the world."

Answered by AI

For whom is this medical experiment best suited?

"This particular medical study is searching for 298 subjects aged 18 to 130 with prostate cancer, who further have confirmed deleterious or suspected deleterious BRCA mutations. Additionally, these participants must also have a malignant solid tumour without an existing treatment protocol and at least one measureable lesion that can be accurately assessed via CT/MRI scans."

Answered by AI

What is the common purpose of olaparib consumption?

"Olaparib is popularly prescribed to treat advanced forms of cancer, such as malignant neoplasm of the ovary and primary peritoneal cancer. It can also be beneficial for managing hallucinations or somatic symptoms."

Answered by AI
~20 spots leftby Apr 2025