Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

NCT02250170 | Completed Phase 1

• 1 other identifier: 317-KOA-1401i
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Number of participants with Adverse Events

  21 days

• Maximum tolerated dose

  The highest dose that does not lead to discontinuation of dose escalation

  21 days

• Biomarker of OPB-111077

  Change from baseline on predictable biomarker specified in the protocol

  21 days

Secondary Outcomes (2)

• 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

Study Arms (1)

OPB-111077

EXPERIMENTAL

Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle)

Drug: OPB-111077

Interventions

OPB-111077 DRUG

Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle)

OPB-111077

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with symptomatic brain metastases
• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Doyoun Oh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Jeehyun Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Sungbae Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: October 23, 2014
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

KR (3)