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Rucaparib for Ovarian Cancer (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

ARIEL3 Trial Summary

This trial will test whether a drug called rucaparib can help people with certain types of cancer that have a particular gene mutation.

Eligible Conditions

Ovarian Cancer
Peritoneal Neoplasm

ARIEL3 Trial 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all patients were followed for survival up to approximately 8.2 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

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 outcome measures

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 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

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

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Anxiety

Neutrophil count decreased

Hypercholesterolaemia

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

Incarcerated hernia

General physical health deterioration

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

ARIEL3 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rucaparib

2016

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

pharmaand GmbHLead Sponsor

21 Previous Clinical Trials

3,611 Total Patients Enrolled

5 Trials studying Ovarian Cancer

1,035 Patients Enrolled for Ovarian Cancer

Clovis Oncology, Inc.Lead Sponsor

64 Previous Clinical Trials

11,107 Total Patients Enrolled

7 Trials studying Ovarian Cancer

1,298 Patients Enrolled for Ovarian Cancer

zr Pharma & GmbHLead Sponsor

20 Previous Clinical Trials

3,528 Total Patients Enrolled

5 Trials studying Ovarian Cancer

1,035 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

Could you tell me how many different facilities are coordinating this clinical trial?

"To make participating as convenient as possible, this trial is being conducted at 30 sites. These locations are situated in Asheville, Miami, Hollywood and other cities. You can choose the location that is closest to you when you sign up."

Answered by AI

What is the official government stance on Rucaparib?

"Rucaparib is rated as a 3 in terms of safety by our team at Power. This score was given because Rucaparib is in Phase 3 trials, meaning that there is data to support its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Does this research paper break new ground in the medical field?

"Rucaparib has had a long history of clinical trials, with the first one being sponsored by Clovis Oncology, Inc. in 2014. This initial study involved 564 patients and following its success Rucaparib received Phase 3 approval. Today, 861 cities across 34 countries are hosting 35 different live trials for Rucaparib."

Answered by AI

Could you direct me to other research regarding Rucaparib's effects?

"Rucaparib was first studied in 2014. Since the completion of the original trial, there have been 18304 more completed clinical trials. At this moment, 35 different rucaparib trials are active with a high concentration being based out North carolina in Asheville."

Answered by AI

Is it possible to sign up for this clinical trial at the moment?

"According to the public database, this trial is not currently looking for patients. The listing was first posted on 4/7/2014 and edited more recently on 6/8/2022. There are 756 other trials that are still recruiting participants."

Answered by AI

How many patients are enrolled in this research project?

"Unfortunately, this particular trial is not searching for any more participants at the moment. The listing was first put up on April 7th, 2014 and updated as recently as June 8th, 2022. However, there are presently 35 other trials involving Rucaparib and 721 trials concerning ovary cancer that require volunteers."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Rucaparib for Patients with Platinum-sensitive, Recurrent Ovarian Carcinoma (ARIEL3): Post-progression Outcomes and Updated Safety Results from a Randomised, Placebo-controlled, Phase 3 Trial

Ledermann, Jonathan A, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, et al.. 2020. “Rucaparib for Patients with Platinum-sensitive, Recurrent Ovarian Carcinoma (ARIEL3): Post-progression Outcomes and Updated Safety Results from a Randomised, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30061-9.

The LancetJournal

Rucaparib Maintenance Treatment for Recurrent Ovarian Carcinoma After Response to Platinum Therapy (ARIEL3): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Coleman, Robert L, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, et al.. 2017. “Rucaparib Maintenance Treatment for Recurrent Ovarian Carcinoma After Response to Platinum Therapy (ARIEL3): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)32440-6.

Gynecologic OncologyJournal

The Effect of Age on Efficacy, Safety and Patient-centered Outcomes with Rucaparib: A Post Hoc Exploratory Analysis of ARIEL3, a Phase 3, Randomized, Maintenance Study in Patients with Recurrent Ovarian Carcinoma

Colombo, Nicoletta, Amit M. Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Johanne I. Weberpals, et al.. 2020. “The Effect of Age on Efficacy, Safety and Patient-centered Outcomes with Rucaparib: A Post Hoc Exploratory Analysis of ARIEL3, a Phase 3, Randomized, Maintenance Study in Patients with Recurrent Ovarian Carcinoma”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2020.05.045.

Cancer Chemotherapy and PharmacologyJournal