A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 47
- Locations
- 3
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.
Detailed Description
This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically and/or cytologically confirmed advanced solid tumor
- •Patients who were refractory to standard therapy or for which there are no standard treatment options available
- •Age 20 to 80 years at the time of informed consent
- •Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
- •Patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will
- •Patients who are able to take oral medication
Exclusion Criteria
- •Patients with symptomatic brain metastases
- •Patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria.
- •Patients with active infections needing whole body therapy
- •Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
- •Patients with positive human immunodeficiency virus (HIV) antibody
- •Patients with uncontrollable cardiac diseases
- •Patients with uncontrollable pain by analgesic drugs
- •Patients with a history of organ transplantation
- •Patients who have received another IMP
- •Patients who are pregnant, possibly pregnant, or lactating
- •Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Arms & Interventions
OPB-111077
Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)
Intervention: OPB-111077 (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 21 days
Number of participants with Adverse Events
Maximum tolerated dose
Time Frame: 21 days
The highest dose that does not lead to discontinuation of dose escalation
Biomarker of OPB-111077
Time Frame: 21 days
Change from baseline on predictable biomarker specified in the protocol
Secondary Outcomes
- Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment(3~18 weeks depending on tumor response)
- Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.(21 days)