Clinical trial NCT00836888: ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Official title: ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Tumor
Keywords: ONO-4538
MDX-1106
solid tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
* Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
* ECOG Performance Status of 0-1
* Life expectancy ≥ 3 months
* Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

* History of severe hypersensitivity reactions to other antibodies.
* Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
* Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
* Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
* Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: Cmax at Single Dose
timeFrame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
measure: AUClast at Single Dose
timeFrame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
measure: T1/2 at Single Dose
timeFrame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
measure: Ceoi at Multiple Doses
timeFrame: day 15
Secondary outcomes:
measure: Best Overall Response
timeFrame: up to study completion, every 4 weeks in principle
Other outcomes:
Locations:
city: Kanto Region
country: Japan
state: Kanto
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ohyama Yukiya
role: STUDY_DIRECTOR
References: