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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2021240028 | Registry Identifier | Registry Identifier: |
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ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL. This study is Phase1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (biomarkers) and efficacy of ONO-7018 in patients with relapsed or refractory NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of Tolerability | Experimental | Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7018 | Drug | ONO-7018 tablet(s) are administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities | Observed toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 to assess the tolerability of ONO-7018. | up to 3 weeks after the first dose |
| Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity. | Up to 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of ONO-7018 | Plasma concentration will be assessed to evaluate Pharmacokinetics. | up to 16 weeks after the first dose |
| Maximum observed concentration (Cmax) | To assess the PK profile of ONO-7018 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital | Nagoya | Aichi-ken | Japan | |||
| National Hospital Organization Shibukawa Medical Center |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| up to 16 weeks after the first dose |
| Time to Cmax (Tmax) | To assess the PK profile of ONO-7018 | up to 16 weeks after the first dose |
| Area under the concentration-time curve to the end of the dosing period (AUCtau) | To assess the PK profile of ONO-7018 | up to 16 weeks after the first dose |
| Elimination half-life (T1/2) | To assess the PK profile of ONO-7018 | up to 16 weeks after the first dose |
| Predose trough concentration (Ctrough) | To assess the PK profile of ONO-7018 | up to 16 weeks after the first dose |
| Overall Response Rate (ORR) | Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Complete response rate (CRR) | Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Best overall response (BOR) | Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Duration of response (DOR) | Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Time to response (TTR) | Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Progression-free survival (PFS) | Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma. | through study completion, an average of 1 year |
| Overall survival (OS) | Antitumor activity of ONO-7018 as measured by OS will be assessed. | through study completion, an average of 1 year |
| Percent change of tumor volume | Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018. | through study completion, an average of 1 year |
| Maximum percent reduction of tumor volume | Maximum percent reduction of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018. | through study completion, an average of 1 year |
| Shibukawa-shi |
| Gunma |
| Japan |
| Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital | Hiroshima | Hiroshima | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | Japan |
| The Cancer Institute Hospital of JFCR | Koto-ku | Tokyo | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | Japan |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |