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Continued Olaparib for Cancer (ROSY-O 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 baseline up to approximately 10 years

Awards & highlights

ROSY-O Trial Summary

This trial provides olaparib for patients who continue to benefit from the drug after completing a previous study.

Who is the study for?

This trial is for patients who have previously been in an oncology study with Olaparib and are still benefiting from it. They must have signed consent, not be on prohibited meds, not have unresolved high-grade toxicity or disease progression, and can't get the drug commercially for free.Check my eligibility

What is being tested?

The ROSY-O study aims to continue providing Olaparib to patients who were part of a previous study and are still seeing positive effects. The focus is on those with ovarian or breast cancer who've shown clinical benefits as determined by their doctor.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants should consider potential ongoing side effects they experienced during the initial olaparib trials which could include nausea, fatigue, blood cell count changes among others.

ROSY-O Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 10 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

Safety follow up

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

ROSY-O Trial Design

1Treatment groups

Experimental Treatment

Group I: OlaparibExperimental Treatment1 Intervention

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

4,262 Previous Clinical Trials

288,594,950 Total Patients Enrolled

47 Trials studying Ovarian Cancer

23,558 Patients Enrolled for Ovarian Cancer

Media Library

Olaparib Clinical Trial Eligibility Overview. Trial Name: NCT04421963 — Phase 3

Ovarian Cancer Research Study Groups: Olaparib

Ovarian Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04421963 — Phase 3

Olaparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421963 — Phase 3

Frequently Asked Questions

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

Does this research program have an age limit?

"This trial is available to anyone aged 18 or older, with the maximum age limit being set at 99 years old."

Answered by AI

Has this type of trial been conducted before?

"As of now, there are 197 active Olaparib clinical trials in 59 countries and 1462 cities. The first one was conducted all the way back in 2005 by AstraZeneca. 98 people participated in that Phase 1 study which approved the drug. 63 more studies have been done since then."

Answered by AI

How many locations are conducting this research?

"To make participation more convenient for enrolled patients, this trial is enrolling at 23 sites located near major cities. For example, there are centres in Towson, Pittsburgh and Shreveport. Patients can choose the site that is closest to them to minimize travel time and inconvenience."

Answered by AI

What are the approved indications for Olaparib?

"Olaparib has been approved by the FDA to treat advance directives, malignant neoplasm of ovary, and primary peritoneal cancer."

Answered by AI

Are there any current vacancies in this clinical trial for prospective patients?

"This particular study, which was first posted on August 4th 2020 and last updated October 26th 2022, is not currently seeking new participants. However, there are 1987 other trials that are still enrolling patients."

Answered by AI

Are there any precedents for the use of Olaparib in medical research?

"Olaparib was first studied in 2005. To date, 63 studies have been completed and 197 are actively recruiting clinical trials. Many of these trials are running out of Towson, Maryland."

Answered by AI

Could I possibly join the ranks of those participating in this experiment?

"This clinical trial is seeking 153 participants suffering from breast cancer. These individuals must be between 18 and 99 years old, and derive some benefit from treatment with an AstraZeneca compound. Additionally, patients must have participated in a prior study involving olaparib where they received this medication and saw some improvement; this could either be an open-label or blinded study that was unblinded upon completion."

Answered by AI

What is the official government stance on Olaparib?

"Given that this is a Phase 3 trial with supporting efficacy data and multiple rounds of safety data, Olaparib was given a score of 3 for safety."

Answered by AI

How many patients are enrolled in this clinical trial?

"This particular clinical trial is not currently seeking patients. However, it's worth noting that there are 1790 trials for breast cancer and 197 trials specifically for Olaparib that are actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

2020. "Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04421963.

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