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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
Must not have
Permanent discontinuation from the parent study due to toxicity or disease progression.
Currently receiving treatment with any prohibited medication(s).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 10 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was removed from the main study because of side effects or my disease got worse.
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I am not taking any medications that are not allowed in the study.
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I have severe side effects from a previous study that stopped my treatment.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
9%
Dizziness
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: OlaparibExperimental Treatment1 Intervention
Treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,390 Total Patients Enrolled
46 Trials studying Ovarian Cancer
23,404 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
~24 spots leftby Apr 2025
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