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Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) (ARIEL3 Trial)
Phase 3
Waitlist Available
Research Sponsored by pharmaand GmbH
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 all patients were followed for survival up to approximately 8.2 years.
Awards & highlights
Pivotal Trial
Summary
This trial is testing a pill called rucaparib on ovarian cancer patients with certain gene mutations. The goal is to see if rucaparib can help these patients by stopping their cancer cells from repairing themselves, which could slow down or stop the growth of the cancer. Rucaparib is approved for use in patients with recurring ovarian cancer and advanced prostate cancer linked to specific genetic changes.
Eligible Conditions
- Ovarian Cancer
- Peritoneal Neoplasm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all patients were followed for survival up to approximately 8.2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all patients were followed for survival up to approximately 8.2 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
Secondary study objectives
Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
Individual Model Parameter Estimates of Rucaparib and Covariates Identification
Overall Survival (OS)
+2 moreSide effects data
From 2022 Phase 3 trial • 564 Patients • NCT0196821376%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Pruritus
15%
Rash
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
8%
Anxiety
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RucaparibExperimental Treatment1 Intervention
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Group II: PlaceboPlacebo Group1 Intervention
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
pharmaand GmbHLead Sponsor
21 Previous Clinical Trials
3,610 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,035 Patients Enrolled for Ovarian Cancer
Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
10,467 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,150 Patients Enrolled for Ovarian Cancer
zr Pharma & GmbHLead Sponsor
20 Previous Clinical Trials
3,527 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,035 Patients Enrolled for Ovarian Cancer
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
15,674 Total Patients Enrolled
3 Trials studying Ovarian Cancer
976 Patients Enrolled for Ovarian Cancer
Myriad Genetics, Inc.Industry Sponsor
17 Previous Clinical Trials
5,009 Total Patients Enrolled
3 Trials studying Ovarian Cancer
1,062 Patients Enrolled for Ovarian Cancer
Heidi GiordanoStudy DirectorClovis Oncology, Inc.
1 Previous Clinical Trials
19 Total Patients Enrolled