Clinical trial NCT02250170: Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
Official title: A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2014-09-26
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically and/or cytologically confirmed advanced solid tumor
2. Patients who were refractory to standard therapy or for which there are no standard treatment options available
3. Age 20 to 80 years at the time of informed consent
4. 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
5. 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
6. Patients who are able to take oral medication

Exclusion Criteria:

1. Patients with symptomatic brain metastases
2. 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.
3. Patients with active infections needing whole body therapy
4. Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
5. Patients with positive human immunodeficiency virus (HIV) antibody
6. Patients with uncontrollable cardiac diseases
7. Patients with uncontrollable pain by analgesic drugs
8. Patients with a history of organ transplantation
9. Patients who have received another IMP
10. Patients who are pregnant, possibly pregnant, or lactating
11. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Primary outcomes:
measure: Adverse Events
timeFrame: 21 days
measure: Maximum tolerated dose
timeFrame: 21 days
measure: Biomarker of OPB-111077
timeFrame: 21 days
Secondary outcomes:
measure: Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment
timeFrame: 3~18 weeks depending on tumor response
measure: Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
timeFrame: 21 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Doyoun Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Jeehyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sungbae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: