KCT0009041Not yet recruitingUnknown
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS with Homologous Recombination Deficiency (GAUSS)
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
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 than ovarian cancer and prostate cancer that is not eligible for curative treatment and for which standard of care therapy has failed or does not exist. • Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. • There is no limit on the number of prior treatment regimens. 4) Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L) or centrally confirmed HRD based on whole-genome sequencing (WGS) • HRD definition: WGS-based HRD determination is the comprehensive assessment of the consequence HR-defect across the whole genome and determined by an advanced tool based on a WGS-based mutational signature and copy number profile that are found across samples with known BRCA1/BRCA2 inactivation. This testing approach allows the detection of LOH, LST and TAI, as well as very HRD-specific mutational signatures including such as ID6, SBS3, RS3 and RS5. 5) Has Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 6) Has measurable disease per RECIST v.1.1 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 the last dose. 8) Has adequate organ function • Hemoglobin = 9.0 g/dL • Absolute neutrophil count = 1.5 x 109/L • Platelets = 100 x 109/L • Total bilirubin = 1.5mg/dL • AST (SGOT)/ALT (SGPT) = 2.5 x upper limit of normal (ULN) (= 5 x ULN for participants with liver metastases) • Serum Creatinine = 1.5 x ULN or Estimated CrCl using the Cockcroft-Gault equation = 60ml/min for participants with creatinine levels =1.5 x ULN 9) Willing to provide biopsies from the tumor at screening to the central laboratory. A. In the case of subjects with WGS test results from the KOSMOS-II master study, additional sample collection is not required.
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, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. 3) Has leptomeningeal metastases. 4) Active central nervous system (CNS) lesions (ie, those with radiologically unstable or symptomatic brain lesions). • For those who receive radiation or surgical treatment the subject can be enrolled if the subject is maintained without evidence of CNS disease progression for more than 4 weeks. 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. • For those treated with platinum therapy as neoadjuvant or adjuvant treatment, a disease-free survival of at least 6 months after the last platinum treatment is required. • Previous treatment with platinum for metastatic disease was allowed if the patient had not progressed while on treatment and subsequent progression occurred after 6 months from the last administration of platinum. 6) Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half–life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last does. 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 • For HBsAg is positive, and HBV DNA = LLOQ, enrollment of the subject can be considered. • If the patient with chronic hepatitis B who are HBsAg positive and HBV DNA positive has been taking antiviral drugs for more than 3 months, enrollment of the subject can be considered at the investigator’s discretion. • For IgG anti-HBc is positive (a history of HBV infection) and HBV DNA = LLOQ, enrollment of the subject can be considered. • For Anti-HCV Ab is positive, and HCV RNA = LLOQ, enrollment of the subject can be considered 13) Has a known history of Human Immunodeficiency Virus (HIV) infection. Patients will be eligible if the following criteria are met. • Patients with CD4+ T-cell counts = 350 cells/µL and no history of AIDS-defining opportunistic infection. • Patients agree to antiretroviral therapy (ART) if not currently on ART. 14) Has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 15) Impairment of gastrointestinal function or gastrointestinal disorders (eg, untreated ulcerative disorders; uncontrolled nausea, vomiting, or diarrhea absorption disorder syndrome; small bowel resection. 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 investigational product. 17) Patients who do not consent to adequate contraception throughout the study period. • Wome
Investigators
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