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Alkylating Agent

Niraparib + Carboplatin for Solid Cancers

Phase 1
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced, solid tumor malignancy amenable to biopsy and consent to 4 mandatory biopsies
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is designed to find a recommended dose and schedule of niraparib plus carboplatin for patients with evidence of HRD, as well as to establish the anti-tumor efficacy of the treatment.

Who is the study for?
Adults with advanced solid tumors and specific mutations that affect DNA repair (HR deficiency) are eligible. They must have measurable disease, be in good physical condition, and have tried standard therapies without success or cannot tolerate them. Pregnant women, those with recent other cancers or severe medical issues, and anyone who has had prior treatment with PARP inhibitors are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of niraparib plus carboplatin to find the safest and most effective dose for patients with HR-deficient tumors. It's a Phase I study where doses will gradually increase to determine how well participants' tumors respond according to RECIST v1.1 criteria.See study design
What are the potential side effects?
Potential side effects include blood disorders like anemia, fatigue, digestive issues such as nausea or constipation, nerve problems like tingling sensations in hands/feet (neuropathy), allergic reactions to drug components, heart rate changes due to QT prolongation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are 18 years old or older.
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You are able to perform your daily activities without assistance or with only slight assistance.
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If you have a gene mutation that is known to cause problems with DNA repair, and it has been confirmed by testing and medical literature, you may not be eligible. Variations that are not well understood will also not be eligible.
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You have a specific genetic mutation that affects your body's ability to repair damaged DNA.
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You have a type of cancer that can be examined with a biopsy, and you must agree to have four biopsies during the study.
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If you have a specific genetic mutation that has already been identified, you do not need to have the testing done again, even if it was done some time ago.
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You have already tried and not responded well to the usual first line treatments that help people. If you have refused standard treatment, you can still participate, but it needs to be recorded.
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You are able to swallow pills without crushing or breaking them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor efficacy by overall response rate
Grade 3 and 4 toxicities
Secondary outcome measures
Disease control rate
Median progression free survival
Median survival

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Urinary tract infection
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Depression
4%
Hyperkalemia
4%
Edema limbs
4%
Esophageal ulcer
4%
Neutrophil count decreased
4%
Lung infection
4%
Hypokalemia
4%
Peripheral sensory neuropathy
4%
White blood cell decreased
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Niraparib and CarboplatinExperimental Treatment2 Interventions
Niraparib will be administered orally, once daily for 21 days of each 21-day cycle in escalating doses depending on cohort patient is assigned to. Carboplatin will be administered via an injection on Day 2 of a given 21-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Niraparib
FDA approved

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityOTHER
442 Previous Clinical Trials
145,417 Total Patients Enrolled
Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,479 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,527 Total Patients Enrolled

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03209401 — Phase 1
Homologous Recombination Deficiency Research Study Groups: Niraparib and Carboplatin
Homologous Recombination Deficiency Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03209401 — Phase 1
Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03209401 — Phase 1

Frequently Asked Questions

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

What past experiments have been conducted to measure the effects of Niraparib?

"Bristol Royal Hospital for Children conducted the initial research into niraparib in 2002, and since then 851 studies have been finalized. At present, 792 experiments are being actively pursued with many of them based out of Charlotte, North carolina."

Answered by AI

Are new participants still being invited to participate in this investigation?

"Affirmative. As evidenced on clinicaltrials.gov, this research initiative is recruiting patients right now and has been since the 13th of October in 2017. 146 individuals need to be enrolled at 4 different medical locations with the most recent update being posted on September 27 2022."

Answered by AI

How many participants are currently involved in this clinical investigation?

"Affirmative. According to the information uploaded on clinicaltrials.gov, this medical trial is still seeking patients after being initial posted on October 13th 2017 and last updated September 27th 2022. An estimated 146 individuals will be recruited from 4 different sites."

Answered by AI

What maladies does Niraparib typically work to alleviate?

"Niraparib has been utilized to effectively manage melanoma and can also be prescribed for various other ailments, including non-Hodgkin's Lymphoma, Advanced Sarcoma, as well as Advance Directives."

Answered by AI

Has the FDA granted approval for Niraparib to be used therapeutically?

"Due to the lack of evidence on Niraparib's safety and efficacy, we at Power rated it a 1 on our scale."

Answered by AI
~3 spots leftby Mar 2025