ArticleJapanese journal of clinical oncology2021
The safety, tolerability and pharmacokinetics of niraparib in Japanese patients with solid tumours: results of a phase I dose-escalation study.
Article in Japanese journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Genetic characteristics and targeted treatments of primary bladder and urachal adenocarcinomas: a systematic review with pooled descriptive genomic analyses.Cancer metastasis reviews · 2026Pooled it
- Progress and prospects of targeted therapy and immunotherapy for urachal carcinoma.Frontiers in pharmacology · 2023Pooled it
- Niraparib in pancreatic cancer with germline or somatic DNA damage repair (DDR) gene alterations (BRCA and beyond): a phase II study (NIRA-PANC).The oncologist · 2026Trial
- Multimodal imaging reveals a lysosomal drug reservoir that drives heterogeneous distribution of PARP inhibitors.Nature communications · 2026Article
- Physiologically-Based Pharmacokinetic Modeling of the PARP Inhibitor Niraparib.CPT: pharmacometrics & systems pharmacology · 2026Article
- Clinical sequencing identifies potential actionable alterations in a high rate of urachal and primary bladder adenocarcinomas.Cancer medicine · 2023Article
- Pharmacokinetics and Pharmacodynamics of PARP Inhibitors in Oncology.Clinical pharmacokinetics · 2022Review
Corrections and comments
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Authors and funding
14 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNiraparib is the only poly (adenosine diphosphate-ribose)-polymerase (PARP) inhibitor available as oral monotherapy for maintenance, regardless of BRCA mutational status.
methodsThis phase I, open-label, non-randomized, dose-escalation study was conducted in Japan using a 3 + 3 design. Adults (≥20 years) with metastatic or locally advanced solid tumours were enrolled. Niraparib 200 mg (cohort 1) or 300 mg (cohort 2) was administered once daily in 21-day cycles (no drug holiday between cycles) until progressive disease (PD) or unacceptable toxicity. The primary objective was to evaluate the safety and tolerability of niraparib in Japanese patients with advanced solid tumours. The number of patients with dose-limiting toxicities in cycle 1 and number with treatment-emergent adverse events were primary endpoints. Secondary endpoints were pharmacokinetics and tumour response.
resultsThere were three patients in cohort 1 and six patients in cohort 2. Only one patient, in cohort 2, developed a dose-limiting toxicity (grade 4 platelet count decreased). All patients in both cohorts developed treatment-emergent adverse events. The most common treatment-related treatment-emergent adverse events were decreased appetite (n = 2) in cohort 1, and platelet count decreased as well as aspartate aminotransferase increased (both n = 5) in cohort 2. Mean Cmax and AUC0-24 of niraparib increased dose-proportionally after multiple doses (accumulation ratio of between 1.64 and 3.65); median tmax was 3-4 h. Two patients, both in cohort 2, had a partial response to treatment.
conclusionsNiraparib (200 or 300 mg/day) was tolerable and had a favourable pharmacokinetic profile in Japanese patients with advanced solid tumours.
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