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A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4685 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4685 | Drug | ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities(DLT) | Up to 3 Weeks | |
| Incidence and severity of AEs and SAEs | Through study completion, an average of 1 year | |
| Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities | Through study completion, an average of 1 year | |
| Body temperature | Through study completion, an average of 1 year | |
| Pulse rate | Through study completion, an average of 1 year | |
| Systolic/diastolic blood pressure | Through study completion, an average of 1 year | |
| Change of weight during the trial period | Through study completion, an average of 1 year | |
| Chest X-ray test | Through study completion, an average of 1 year | |
| ECG parameters by 12 lead ECG(pulse rate) | Through study completion, an average of 1 year | |
| ECG parameters by 12 lead ECG(RR) | Through study completion, an average of 1 year | |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response (BOR) | Through study completion, an average of 1 year | |
| Overall response rate (ORR) | Through study completion, an average of 1 year | |
| Complete response rate (CRR) |
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Inclusion Criteria:
Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
Peripheral T-cell lymphoma(PTCL)
Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
ECOG PS 0~2
Life expectancy of at least 3 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| North America Clinical Trial Support Desk | Contact | +18665877745(Toll-Free) | clinical_trial@ono-pharma.com | |
| International Clinical Trial Support Desk | Contact | +17162141777(Standard) | clinical_trial@ono-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Recruiting | Nagoya | Aichi-ken | Japan | ||
| Nagoya University Hospital |
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| ECG parameters by 12 lead ECG(QT interval) |
| Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB]) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(PR interval) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(QRS) | Through study completion, an average of 1 year |
| Through study completion, an average of 1 year |
| Duration of response (DOR) | Through study completion, an average of 1 year |
| Progression Free Survival(PFS) | Through study completion, an average of 1 year |
| Time to response (TTR) | Through study completion, an average of 1 year |
| Overall Survival(OS) | Through study completion, an average of 1 year |
| The percent change of tumor volume | Through study completion, an average of 1 year |
| Pharmacokinetics(Cmax) | Through study completion, an average of 1 year |
| Pharmacokinetics(Tmax) | Through study completion, an average of 1 year |
| Pharmacokinetics(AUC) | Through study completion, an average of 1 year |
| Pharmacokinetics(Ceoi) | Through study completion, an average of 1 year |
| Pharmacokinetics(T1/2) | Through study completion, an average of 1 year |
| Pharmacokinetics(Ctrough) | Through study completion, an average of 1 year |
| Volume of distribution(Vd) | Through study completion, an average of 1 year |
| clearance(CL) | Through study completion, an average of 1 year |
| Anti-ONO-4685 antibody | Through study completion, an average of 1 year |
| Recruiting |
| Nagoya |
| Aichi-ken |
| Japan |
| Akita University Hospital | Recruiting | Akita | Akita | Japan |
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | Japan |
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
| Hokkaido University Hospital | Recruiting | Sapporo | Hokkaido | Japan |
| Tokai University Hospital | Recruiting | Isehara-shi | Kanagawa | Japan |
| Kumamoto University Hospital | Recruiting | Kumamoto | Kumamoto | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Recruiting | Kyoto | Kyoto | Japan |
| Tohoku University Hospital | Recruiting | Sendai | Miyagi | Japan |
| Okayama University Hospital | Recruiting | Okayama | Okayama-ken | Japan |
| Kindai University Hospital | Recruiting | Osaka Sayama-shi | Osaka | Japan |
| Osaka University Hospital | Not yet recruiting | Osaka-fu | Osaka | Japan |
| Cancer Institute Hospital of JFCR | Recruiting | Koto-ku | Tokyo | Japan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016399 | Lymphoma, T-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
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