A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGNagoya University Hospital
Nagoya, Aichi-ken, Japan
Dose-limiting toxicities(DLT)
Time frame: Up to 3 Weeks
Incidence and severity of AEs and SAEs
Time frame: Through study completion, an average of 1 year
Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
Time frame: Through study completion, an average of 1 year
Body temperature
Time frame: Through study completion, an average of 1 year
Pulse rate
Time frame: Through study completion, an average of 1 year
Systolic/diastolic blood pressure
Time frame: Through study completion, an average of 1 year
Change of weight during the trial period
Time frame: Through study completion, an average of 1 year
Chest X-ray test
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(pulse rate)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(RR)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QT interval)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])
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CONTACT
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Akita University Hospital
Akita, Akita, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
RECRUITINGKyushu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGHokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGTokai University Hospital
Isehara-shi, Kanagawa, Japan
RECRUITINGKumamoto University Hospital
Kumamoto, Kumamoto, Japan
RECRUITINGUniversity Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
RECRUITINGTohoku University Hospital
Sendai, Miyagi, Japan
RECRUITING...and 4 more locations
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(PR interval)
Time frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QRS)
Time frame: Through study completion, an average of 1 year
Best overall response (BOR)
Time frame: Through study completion, an average of 1 year
Overall response rate (ORR)
Time frame: Through study completion, an average of 1 year
Complete response rate (CRR)
Time frame: Through study completion, an average of 1 year
Duration of response (DOR)
Time frame: Through study completion, an average of 1 year
Progression Free Survival(PFS)
Time frame: Through study completion, an average of 1 year
Time to response (TTR)
Time frame: Through study completion, an average of 1 year
Overall Survival(OS)
Time frame: Through study completion, an average of 1 year
The percent change of tumor volume
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Cmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Tmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(AUC)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Ceoi)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(T1/2)
Time frame: Through study completion, an average of 1 year
Pharmacokinetics(Ctrough)
Time frame: Through study completion, an average of 1 year
Volume of distribution(Vd)
Time frame: Through study completion, an average of 1 year
clearance(CL)
Time frame: Through study completion, an average of 1 year
Anti-ONO-4685 antibody
Time frame: Through study completion, an average of 1 year