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Chemotherapy

Rucaparib for Ovarian Cancer

Phase 3

Waitlist Available

Research Sponsored by Clovis Oncology, Inc.

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 3.5 years.

Awards & highlights

Study Summary

This trial is testing whether a new drug, rucaparib, is better than chemotherapy at treating ovarian, fallopian tube, and primary peritoneal cancer.

Eligible Conditions

Ovarian Cancer
Peritoneal Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all patients were followed for survival up to approximately 3.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all patients were followed for survival up to approximately 3.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all patients were followed for survival up to approximately 3.5 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

Pharmacotherapy

Secondary outcome measures

Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)

Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)

Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)

+7 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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RucaparibExperimental Treatment1 Intervention

Drug: Oral rucaparib 600 mg BID (twice a day) Other Names: CO-338 PF 01367338 AG 14699 Rubraca

Group II: ChemotherapyActive Control1 Intervention

Monotherapy platinum (cisplatin or carboplatin) or platinum-based doublet chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision. Single agent paclitaxel will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.

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?

Clovis Oncology, Inc.Lead Sponsor

64 Previous Clinical Trials

11,322 Total Patients Enrolled

7 Trials studying Ovarian Cancer

1,513 Patients Enrolled for Ovarian Cancer

pharmaand GmbHLead Sponsor

21 Previous Clinical Trials

3,826 Total Patients Enrolled

5 Trials studying Ovarian Cancer

1,250 Patients Enrolled for Ovarian Cancer

zr Pharma & GmbHLead Sponsor

20 Previous Clinical Trials

3,743 Total Patients Enrolled

5 Trials studying Ovarian Cancer

1,250 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.

Has Rucaparib received FDA approval for therapeutic use?

"There is some supporting evidence for Rucaparib's efficacy, and it has undergone multiple safety trials, giving it a score of 3."

Answered by AI

What are the main illnesses that Rucaparib has been known to help with?

"Rucaparib has been show to be effective in initial treatments for non-small cell lung cancer, as well as locally advanced non-Hodgkin's lymphoma."

Answered by AI

How many people are being considered for this clinical trial?

"Unfortunately, this particular trial is no longer enrolling new participants. The clinical trial was initially posted on March 1st, 2017 and last updated on February 20th, 2022. If you are interested in other trials, there are 765 trials for fallopian tubes cancer and 1775 trials for Rucaparib that are still recruiting patients."

Answered by AI

Are there other examples where Rucaparib has been used in scientific research?

"Rucaparib was first studied in 1997 at City of Hope Comprehensive Cancer Center. As of today, there have been a total of 2833 completed trials. Currently, there are 1775 clinical trials recruiting patients, with a large number of these studies based in Ottawa, Quebec."

Answered by AI

How many different places can patients access this trial?

"Currently, there are 13 active recruitment sites for this clinical trial. These locations are situated in major cities such as Ottawa, Montréal, and Calgary. To reduce the inconvenience of travel, it is best to select a recruitment site nearest to your location."

Answered by AI

Are there any current participants in this study?

"From what is published on clinicaltrials.gov, it appears that this particular trial is no longer looking for volunteers. The listing was first created on March 1st, 2017 and was last updated on February 20th, 2022. However, there are 2,540 other trials that are still currently open."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Rucaparib Versus Standard-of-care Chemotherapy in Patients with Relapsed Ovarian Cancer and a Deleterious BRCA1 or BRCA2 Mutation (ARIEL4): An International, Open-label, Randomised, Phase 3 Trial

Kristeleit, Rebecca, Alla Lisyanskaya, Alexander Fedenko, Mikhail Dvorkin, Andreia Cristina de Melo, Yaroslav Shparyk, Irina Rakhmatullina, et al.. 2022. “Rucaparib Versus Standard-of-care Chemotherapy in Patients with Relapsed Ovarian Cancer and a Deleterious BRCA1 or BRCA2 Mutation (ARIEL4): An International, Open-label, Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00122-x.

The Lancet OncologyJournal

Rucaparib Versus Standard-of-care Chemotherapy in Patients with Relapsed Ovarian Cancer and a Deleterious BRCA1 or BRCA2 Mutation (ARIEL4): An International, Open-label, Randomised, Phase 3 Trial

clinicaltrials.govStudy

ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

2017. "ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02855944.