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

Launched by KOREA UNIVERSITY ANAM HOSPITAL · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Niraparib (ZEJULA®) in patients with advanced solid tumors that have specific genetic mutations affecting DNA repair, known as homologous recombination deficiency (HRD). The trial aims to see how well this drug works for adults with tumors that cannot be surgically removed or have spread to other parts of the body. To participate, patients need to be at least 19 years old, have a confirmed diagnosis of an advanced solid tumor, and have certain genetic mutations identified through testing.

If eligible, participants can expect to be part of the study for up to three years, during which they will receive the medication and provide tumor samples for further analysis. It's important to note that individuals with certain health conditions or those who have received specific prior treatments may not be able to join the study. The trial is not yet recruiting participants, so interested individuals will need to wait for more information on when it will start.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient who agreed to participate in the KOSMOS-II master observation study.
• • 2. 19 years of age or older on the day of signing informed consent.
• • 3. Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
• • 4. 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).
• • 5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • 6. Has measurable disease per RECIST v1.1 as assessed by the local site investigator.
• • 7. 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.
• • 8. Has adequate organ function.
• • 9. Willing to provide biopsies from the tumor at screening to the central laboratory
• Exclusion Criteria:
• • 1. Any previous exposure to PARP inhibitor
• • 2. Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment
• • 3. Has leptomeningeal metastases.
• • 4. Active central nervous system (CNS) lesions.
• • 5. Were resistant to prior platinum therapy (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor.
• • 6. Any cytotoxic chemotherapy from a previous treatment regimen within 14 days.
• • 7. Has received prior endocrine therapy as cancer treatment within 2 weeks prior to administration of study intervention.
• • 8. Has received palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of the first dose of study treatment.
• • 9. Has an active infection requiring systemic therapy.
• • 10. Has hypertension that cannot be adequately controlled with medication.
• • 11. Has active tuberculosis.
• • 12. Has active infection such as hepatitis B, hepatitis C
• • 13. Has a known history of Human Immunodeficiency Virus (HIV) infection.
• • 15) 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.
• • 17) Patients who do not consent to adequate contraception throughout the study period.
• • 18) Has a known hypersensitivity to the components of the investigational product or its analogs.
• • 19) Since this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• • 20) Since this drug contains Yellow No. 4 (Tartrazine), patients with a history of hypersensitivity or allergy to this ingredient.
• • 21) Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial.
• • 22) The investigator judges that it is not appropriate to participate in this study for else reasons.