Phase 1
N=17
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Malignant Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00836888 ↗Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Oct 2020
Primary outcome: Primary: Cmax at Single Dose — 24.4; 68.8; 192; 214 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ONO-4538 (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax at Single Dose |
24.4; 68.8; 192; 214 | — |
| PRIMARY AUClast at Single Dose |
4950; 12300; 43900; 67400 | — |
| PRIMARY T1/2 at Single Dose |
15; 13; 21; 17 | — |
| PRIMARY Ceoi at Multiple Doses |
29.3; 101; 270; 286 | — |
| SECONDARY Best Overall Response |
0; 1; 0; 0; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00836888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.