Non Hodgkin Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGONO-7018
ONO-7018 tablet(s) are administered orally.
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with histologically/cytologically confirmed diagnosis of any of the subtypes of B-cell NHL or T-cell NHL defined below as documented by medical records and with histology based on criteria established by the World Health Organization (Swerdlow 2017) 2. Relapsed or refractory patient who is refractory or intolerant to standard therapy or for whom, in the opinion of the investigator, there is no appropriate treatment for the primary disease. 3. Patient who has measurable disease 4. Eastern Cooperative Oncology Group Performance Status 0 to 2 5. Life expectancy of at least 3 months
Exclusion criteria
1. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results 2. Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria 3. Prior treatment with a MALT1 inhibitor 4. Patient is unable to swallow tablets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicities | up to 3 weeks after the first dose | 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. |
| Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Up to 28 days after the last dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of ONO-7018 | up to 16 weeks after the first dose | Plasma concentration will be assessed to evaluate Pharmacokinetics. |
| Maximum observed concentration (Cmax) | up to 16 weeks after the first dose | To assess the PK profile of ONO-7018 |
| Time to Cmax (Tmax) | up to 16 weeks after the first dose | To assess the PK profile of ONO-7018 |
| Area under the concentration-time curve to the end of the dosing period (AUCtau) | up to 16 weeks after the first dose | To assess the PK profile of ONO-7018 |
| Elimination half-life (T1/2) | up to 16 weeks after the first dose | To assess the PK profile of ONO-7018 |
| Predose trough concentration (Ctrough) | up to 16 weeks after the first dose | To assess the PK profile of ONO-7018 |
| Overall Response Rate (ORR) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma. |
| Complete response rate (CRR) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma. |
| Best overall response (BOR) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma. |
| Duration of response (DOR) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma. |
| Time to response (TTR) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma. |
| Progression-free survival (PFS) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma. |
| Overall survival (OS) | through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by OS will be assessed. |
| Percent change of tumor volume | through study completion, an average of 1 year | Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018. |
| Maximum percent reduction of tumor volume | through study completion, an average of 1 year | 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. |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed