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PARP Inhibitor

Rucaparib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Jonathan W Riess

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.

Patients must not have a >= Grade 3 hypercholesterolaemia (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) within 28 days prior to sub-study registration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to a maximum of 3 years or death

Awards & highlights

Study Summary

This trial tests how well rucaparib works to treat patients with stage IV non-small cell lung cancer that has come back or has a BRCA1/2 mutation.

Who is the study for?

This trial is for adults with stage IV or recurrent non-small cell lung cancer that have high genomic loss of heterozygosity (LOH) or harmful BRCA1/2 mutations. Participants must be able to take oral medications, not have certain liver conditions, infections, or recent major surgeries. They should not have had prior treatment with PARP inhibitors and must agree to use effective contraception if of reproductive potential.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Rucaparib, a drug designed to block enzymes needed for tumor growth in patients with specific genetic profiles related to lung cancer. It's a phase II study which means it focuses on the drug's efficacy and side effects.See study design

What are the potential side effects?

While specific side effects for Rucaparib are not listed here, common ones from drugs like this include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have severe heart disease or recent serious heart issues.

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I do not have severe high cholesterol as defined by recent medical standards.

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I can take pills by mouth.

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My bilirubin levels are within the normal range, even with liver metastases.

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I don't have specific genetic mutations in my cancer or I've tried all standard treatments for them.

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I've had a brain scan within the last 42 days and don't have untreated brain issues.

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I do not have acute hepatitis or any active infections.

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I haven't had chemotherapy, immunotherapy, or experimental drugs in the last 21 days and have recovered from their side effects. I also haven't had radiation therapy in the last 14 days.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be seen on scans and has been checked within the last month.

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I have never been treated with PARP inhibitors for my condition.

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I am assigned to S1900A with specific genetic markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to a maximum of 3 years or death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration to a maximum of 3 years or death

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to a maximum of 3 years or death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Duration of Response (DoR)

Investigator-Assessed Progression-Free Survival (IA-PFS)

Pharmaceutical Preparations

+1 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

1Treatment groups

Experimental Treatment

Group I: Treatment (rucaparib)Experimental Treatment1 Intervention

Patients receive rucaparib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rucaparib

2016

Completed Phase 3

~1990

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

265,106 Total Patients Enrolled

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,747 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,089 Total Patients Enrolled

1 Trials studying BRCA2 Mutation

18 Patients Enrolled for BRCA2 Mutation

Media Library

Rucaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03845296 — Phase 2

BRCA2 Mutation Research Study Groups: Treatment (rucaparib)

BRCA2 Mutation Clinical Trial 2023: Rucaparib Highlights & Side Effects. Trial Name: NCT03845296 — Phase 2

Rucaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845296 — Phase 2

Frequently Asked Questions

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

What kind of side effects does Rucaparib have on patients?

"There is some data supporting Rucaparib's safety, but none to suggest that the medication is effective. Therefore, it received a score of 2."

Answered by AI

What other research has been done on Rucaparib's effectiveness?

"Rucaparib was first studied in 2014 at Sourasky Medical Center. There have been a total of 15 completed trials thus far. As of now, there are 35 active trials taking place; many of them located in Winston-Salem, North carolina."

Answered by AI

What are the desired outcomes of this research?

"The primary metric by which the success of this clinical trial will be measured is progression-free survival as assessed by an investigator, over a period of 3 years or until death. Secondary outcomes include duration of response, number of participants with grade 3-5 adverse events related to study drugs, and overall survival."

Answered by AI

Is this a ground-breaking clinical trial?

"Rucaparib has undergone 35 clinical trials in 861 cities and 34 countries since the first study in 2014. The initial Rucaparib study, sponsored by Clovis Oncology, Inc., completed Phase 3 drug approval with 564 participants. In the 6 years since, 15 more studies have been conducted."

Answered by AI

Are people still being enrolled in this trial?

"Unfortunately, this study is no longer enrolling patients. Although it was active from 1/28/2019-9/23/2022, the trial has now concluded. However, there are 35 other studies for Rucaparib and 5241 trials actively recruiting participants with loss of heterozygosity that may be of interest."

Answered by AI

How many individuals are being given this medication as part of the research?

"This study has completed recruitment for participants. The clinical trial was first posted on 1/28/2019 and was most recently updated on 9/23/2022. If you are exploring other studies, there are presently 5241 trials actively recruiting participants with loss of heterozygosity and 35 studies for Rucaparib actively looking for patients."

Answered by AI

How many hospitals are running this trial?

"There are a total of 10 enrolling sites for this clinical trial, which are listed as follows: Novant Health Oncology Specialists in Winston-Salem, North carolina, Rapid City Regional Hospital in Rapid City, South dakota, UM Sylvester Comprehensive Cancer Center at Coral Gables in Coral Gables, Illinois. The other 7 locations can be found on the website."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

2019. "Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03845296.

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