--- title: ONO-4538 Phase II Rollover Study (ONO-4538-98) nct_id: NCT04566380 overall_status: RECRUITING phase: PHASE2 sponsor: Ono Pharmaceutical Co., Ltd. study_type: INTERVENTIONAL primary_condition: Pan-tumor countries: Japan, South Korea, Taiwan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04566380.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04566380" ct_last_update_post_date: 2025-06-03 last_seen_at: "2026-05-12T06:58:34.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # ONO-4538 Phase II Rollover Study (ONO-4538-98) **Official Title:** A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98) **NCT ID:** [NCT04566380](https://clinicaltrials.gov/study/NCT04566380) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 59 - **Lead Sponsor:** Ono Pharmaceutical Co., Ltd. - **Conditions:** Pan-tumor - **Start Date:** 2020-09-10 - **Completion Date:** 2026-12-31 - **CT.gov Last Update:** 2025-06-03 ## Brief Summary This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials. ## Eligibility - **Minimum age:** 16 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials 2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit Exclusion Criteria: 1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia 2. Participant judged by the investigator to be inappropriate as participants of this study ``` ## Arms - **ONO-4538 Monotherapy cohort** (EXPERIMENTAL) — 480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice - **Combination therapy cohort** (EXPERIMENTAL) — ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. ## Interventions - **ONO-4538** (DRUG) — IV infusion over 30 minutes - **oxaliplatin** (DRUG) — IV infusion over 2 hours - **S-1** (DRUG) — Administered orally twice daily - **capecitabine** (DRUG) — Administered orally twice daily - **bevacizumab** (DRUG) — IV infusion over 30 minutes - **temozolomide** (DRUG) — Administered orally once daily for 5 days every 28 days ## Primary Outcomes - **Incidence of Adverse Events (Aes)** _(time frame: From Day 1 up to 28 days after the end of the treatment phase)_ — (non) ## Locations (38) - Chiba Clinical Site1, Kashiwa, Chiba, Japan — _RECRUITING_ - Ehime Clinical Site1, Matsuyama, Ehime, Japan — _COMPLETED_ - Fukuoka Clinical Site1, Kurume, Fukuoka, Japan — _RECRUITING_ - Hokkaido Clinical Site1, Sapporo, Hokkaido, Japan — _RECRUITING_ - Hyogo Clinical Site1, Akashi, Hyōgo, Japan — _RECRUITING_ - Kanagawa Clinical Site1, Yokohama, Kanagawa, Japan — _RECRUITING_ - Oita Clinical Site1, Yufu, Oita Prefecture, Japan — _RECRUITING_ - Osaka Clinical Site1, Suita, Osaka, Japan — _RECRUITING_ - Osaka Clinical Site3, Takatsuki, Osaka, Japan — _RECRUITING_ - Saitama Clinical Site1, Hidaka, Saitama, Japan — _RECRUITING_ - Saitama Clinical Site2, Kitaadachi-gun, Saitama, Japan — _RECRUITING_ - Tokyo Clinical Site3, Bunkyo-ku, Tokyo, Japan — _RECRUITING_ - Tokyo Clinical Site2, Chuo-ku, Tokyo, Japan — _RECRUITING_ - Tokyo Clinical Site1, Koto-ku, Tokyo, Japan — _RECRUITING_ - Tokyo Clinical Site4, Shinjuku-ku, Tokyo, Japan — _RECRUITING_ - Chiba Clinical Site2, Chiba, Japan — _RECRUITING_ - Fukuoka Clinical Site2, Fukuoka, Japan — _RECRUITING_ - Fukuoka Clinical Site3, Fukuoka, Japan — _RECRUITING_ - Hiroshima Clinical Site1, Hiroshima, Japan — _RECRUITING_ - Kyoto Clinical Site1, Kyoto, Japan — _RECRUITING_ - Okayama Clinical Site1, Okayama, Japan — _RECRUITING_ - Osaka Clinical Site2, Osaka, Japan — _RECRUITING_ - Daegu Clinical Site1, Daegu, South Korea — _RECRUITING_ - Gyeonggi-do Clinical site1, Gyeonggi-do, South Korea — _RECRUITING_ - Incheon Clinical Site1, Incheon, South Korea — _RECRUITING_ - Seoul Clinical Site1, Seoul, South Korea — _RECRUITING_ - Seoul Clinical Site2, Seoul, South Korea — _COMPLETED_ - Seoul Clinical Site3, Seoul, South Korea — _RECRUITING_ - Seoul Clinical Site4, Seoul, South Korea — _RECRUITING_ - Seoul Clinical Site5, Seoul, South Korea — _RECRUITING_ - Seoul Clinical Site6, Seoul, South Korea — _RECRUITING_ - Kaohsiung Clinical Site1, Kaohsiung City, Taiwan — _COMPLETED_ - Kaohsiung Clinical Site2, Kaohsiung City, Taiwan — _COMPLETED_ - Tainan Clinical Site1, Tainan, Taiwan — _RECRUITING_ - Tainan Clinical Site2, Tainan, Taiwan — _RECRUITING_ - Taipei Clinical Site1, Taipei, Taiwan — _RECRUITING_ - Taipei Clinical Site2, Taipei, Taiwan — _RECRUITING_ - Taoyuan Clinical Site1, Taoyuan, Taiwan — _RECRUITING_ ## Recent Field Changes (last 30 days) - `locations.tokyo clinical site4|shinjuku-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.chiba clinical site2|chiba||japan` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.chiba clinical site1|kashiwa|chiba|japan` — added _(2026-05-12)_ - `locations.ehime clinical site1|matsuyama|ehime|japan` — added _(2026-05-12)_ - `locations.fukuoka clinical site1|kurume|fukuoka|japan` — added _(2026-05-12)_ - `locations.hokkaido clinical site1|sapporo|hokkaido|japan` — added _(2026-05-12)_ - `locations.hyogo clinical site1|akashi|hyōgo|japan` — added _(2026-05-12)_ - `locations.kanagawa clinical site1|yokohama|kanagawa|japan` — added _(2026-05-12)_ - `locations.oita clinical site1|yufu|oita prefecture|japan` — added _(2026-05-12)_ - `locations.osaka clinical site1|suita|osaka|japan` — added _(2026-05-12)_ - `locations.osaka clinical site3|takatsuki|osaka|japan` — added _(2026-05-12)_ - `locations.saitama clinical site1|hidaka|saitama|japan` — added _(2026-05-12)_ - `locations.saitama clinical site2|kitaadachi-gun|saitama|japan` — added _(2026-05-12)_ - `locations.tokyo clinical site3|bunkyo-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.tokyo clinical site2|chuo-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.tokyo clinical site1|koto-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.fukuoka clinical site2|fukuoka||japan` — added _(2026-05-12)_ - `locations.fukuoka clinical site3|fukuoka||japan` — added _(2026-05-12)_ - `locations.hiroshima clinical site1|hiroshima||japan` — added _(2026-05-12)_ - `locations.kyoto clinical site1|kyoto||japan` — added _(2026-05-12)_ - `locations.okayama clinical site1|okayama||japan` — added _(2026-05-12)_ - `locations.osaka clinical site2|osaka||japan` — added _(2026-05-12)_ - `locations.daegu clinical site1|daegu||south korea` — added _(2026-05-12)_ - `locations.gyeonggi-do clinical site1|gyeonggi-do||south korea` — added _(2026-05-12)_ - `locations.incheon clinical site1|incheon||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site1|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site2|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site3|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site4|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site5|seoul||south korea` — added _(2026-05-12)_ - `locations.seoul clinical site6|seoul||south korea` — added _(2026-05-12)_ - `locations.kaohsiung clinical site1|kaohsiung city||taiwan` — added _(2026-05-12)_ - `locations.kaohsiung clinical site2|kaohsiung city||taiwan` — added _(2026-05-12)_ - `locations.tainan clinical site1|tainan||taiwan` — added _(2026-05-12)_ - `locations.tainan clinical site2|tainan||taiwan` — added _(2026-05-12)_ - `locations.taipei clinical site1|taipei||taiwan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04566380.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04566380* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*