Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

NCT06237205 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: GAUSS
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing

Conditions

Efficacy

Outcome Measures

Primary Outcomes (1)

• objective response after 8 weeks

  Antitumor activity defined as objective response after 8 weeks

  at 8 weeks after Cycle 1 Day 1(each cycle is 28 days)

Study Arms (1)

Niraparib

EXPERIMENTAL

Drug: Niraparib

Interventions

Niraparib DRUG

a highly selective PARP1 and PARP2 inhibitor

Niraparib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who agreed to participate in the KOSMOS-II master observation study.
• years of age or older on the day of signing informed consent.
• Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
• Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Has measurable disease per RECIST v1.1 as assessed by the local site investigator.
• Female participants of reproductive potential must agree to use contraception during the treatment period and for at least 6 months after the last dose. Male participants must agree to use contraception during the treatment period and for 90 days plus 5 X half-life after last dose.
• Has adequate organ function.
• Willing to provide biopsies from the tumor at screening to the central laboratory

You may not qualify if:

• Any previous exposure to PARP inhibitor
• Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment
• Has leptomeningeal metastases.
• Active central nervous system (CNS) lesions.
• Were resistant to prior platinum therapy (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor.
• Any cytotoxic chemotherapy from a previous treatment regimen within 14 days.
• Has received prior endocrine therapy as cancer treatment within 2 weeks prior to administration of study intervention.
• Has received palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of the first dose of study treatment.
• Has an active infection requiring systemic therapy.
• Has hypertension that cannot be adequately controlled with medication.
• Has active tuberculosis.
• Has active infection such as hepatitis B, hepatitis C
• Has a known history of Human Immunodeficiency Virus (HIV) infection.
• \) Impairment of gastrointestinal function or gastrointestinal disorders 16) Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of the Investigational product.
• \) Patients who do not consent to adequate contraception throughout the study period.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Takeda: collaborator
• Korean Cancer Study Group: collaborator

MeSH Terms

Interventions

niraparib

Central Study Contacts

soohyeon lee, phd

CONTACT

+82-2-920-6078; soohyeon_lee@korea.ac.kr

chanju park, bs

CONTACT

+82-2-920-6078; ckswn4869@kumc.or.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 1, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 1, 2024

Record last verified: 2024-01