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

ConditionEfficacy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Anam Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient who agreed to participate in the KOSMOS-II master observation study.

19 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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Niraparib

    Drug

    a highly selective PARP1 and PARP2 inhibitor

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: NiraparibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

objective response after 8 weeks

Antitumor activity defined as objective response after 8 weeks

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Takeda

Collaborator

Korean Cancer Study Group

Collaborator

This trial is not recruiting at the moment. You can still explore other options: