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Completed

NCT Number: NCT02250170

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

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.

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Key information

Conditions

Solid Tumor

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPB-111077

Drug

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

Primary outcomes

  1. Adverse Events

    Time frame: 21 days

    Number of participants with Adverse Events

  2. Maximum tolerated dose

    Time frame: 21 days

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

  3. Biomarker of OPB-111077

    Time frame: 21 days

    Change from baseline on predictable biomarker specified in the protocol

Secondary outcomes

  1. Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment

    Time frame: 3~18 weeks depending on tumor response

    Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the final study visit.

  2. Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.

    Time frame: 21 days

    The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2014
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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