~3 spots leftby Mar 2026

Niraparib + Carboplatin for Solid Cancers

Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Georgetown University
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway (HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Eligibility Criteria

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.

Inclusion Criteria

Advanced, solid tumor malignancy amenable to biopsy and consent to 4 mandatory biopsies
ECOG performance status (PS) of 0 to 1
Received and failed or intolerant to standard first line therapies or documented refusal
Adequate hepatic, bone marrow, and renal function at enrollment
Patients PRE-identified with germline or tumor deleterious mutation in DNA damage repair genes through Next-generation DNA sequencing
You are 18 years old or older.
You are able to perform your daily activities without assistance or with only slight assistance.
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.
Somatic mutations PRE-identified through NGS in CLIA certified, CAP tested, and bioinformatics-validated testing lab
You have a specific genetic mutation that affects your body's ability to repair damaged DNA.
You have a type of cancer that can be examined with a biopsy, and you must agree to have four biopsies during the study.
You are able to swallow pills without crushing or breaking them.

Exclusion Criteria

Prior PARP inhibitor-based therapy
You have a digestive system disorder that affects how your body absorbs medication.
Prior disease progression while receiving platinum chemotherapy or platinum chemotherapy within the last 6 months
Active severe infection or known chronic infection with HIV or hepatitis B virus
Cardiovascular disease problems within the last 6 months or QT prolongation ≥ 481 milliseconds
Life-threatening visceral disease or severe concurrent disease causing unacceptable safety risks or compromising compliance
Radiotherapy encompassing >20% of the bone marrow
Known, persistent > Grade 2 toxicity from prior cancer therapy
Known history of myelodysplastic syndrome (MDS)

Participant Groups

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.
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.
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Yale University, Yale Cancer CenterNew Haven, CT
Sibley Memorial HospitalWashington, United States
Lombardi Comprehensive Cancer CenterWashington, United States
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, NJ
More Trial Locations
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Who is running the clinical trial?

Georgetown UniversityLead Sponsor
Thomas Jefferson UniversityCollaborator
Tesaro, Inc.Industry Sponsor
Oregon Health and Science UniversityCollaborator

References