ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Malignant Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836888
• Other study ID #: ONO-4538-01
• Status: Completed
• Phase: Phase 1
• Start date: January 2009

Study information

• Verified date: April 2015
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Tumor
• Neoplasms

Intervention

Biological:
• ONO-4538
1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax at Single Dose		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
Primary	AUClast at Single Dose		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
Primary	T1/2 at Single Dose		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
Primary	Ceoi at Multiple Doses	Ceoi:Serum concentrations immediately after the end of continuous administration	day 15
Secondary	Best Overall Response	Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure.; Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.	up to study completion, every 4 weeks in principle