Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

March 24, 2014 updated by: Otsuka Beijing Research Institute

A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In expansion stage part 1, up to 20 advanced sold tumor subjects will be investigated the safety profiled and antitumor effect of OPB-51602 at the recommended dose for 3 weeks per cycle（2 weeks treatment and 1 week washout). In the expansion stage part 2, a maximum of 20 subjects with Non-small cell lung cancer (NSCLC), Melanoma or Gastrointestinal Stromal Tumor (GIST) will be treated until an investigational Medicinal product (IMP) efficacious case can be found. subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in cycle 1. After safety and tolerability are confirmed, same subjects will be treated at the MTD(5mg) from cycle 2 onwards as a once-daily oral dose for 4 weeks per cycle to obtain additional information about safety, tolerability and antitumor activity of OPB-51602

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital (s) PTE LTD.
      • Singapore, Singapore, 160610
        • National Cancer Centre, Department of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with pathologically confirmed, locally advanced or metastatic solid tumors who are unresponsive to standard therapy or for whom standard therapy is intolerable or unsuitable
  • Age: ≥21 years (at time of informed consent)
  • ECOG performance status: ≤2 (Appendix 1)
  • Life expectancy of longer than 3 months

  • Adequate vital organ function as follows:

    1. Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin: ≥9.0 g/dL
    2. Hepatic function Aspartate transaminase (AST) and alanine transaminase(ALT): ≤2.5 ×institutional upper limit of normal(ULN) or ≤5.0 × institutional ULN if there is liver metastasis, serum total bilirubin: <2.5 × institutional ULN
    3. Renal function Serum creatinine: <1.5 × institutional ULN
  • Capable of swallowing OPB-51602 tablets
  • Ability to understand and willingness to sign written informed consent form (ICF) for participation in the trial
  • No chemotherapy, radiotherapy, surgery, immunotherapy, or other therapy within 4 weeks prior to start of investigational medicinal product (IMP) administration and recovered from any prior toxicity
  • If a subject has received more than 5 regimens of previous chemotherapy, the investigator must discuss with the sponsor regarding subject suitability prior to enrollment.

Exclusion Criteria:

  • Uncontrolled central nervous system (CNS) metastasis
  • Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart Association (NYHA) functional classification)
  • Concurrent malignancy of a different type
  • Immunocompromised subjects, including those who are known to be infected with human immunodeficiency virus (HIV)
  • Psychiatric illness that would limit compliance with trial requirements
  • Pregnant or breast-feeding women
  • Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who cannot or will not use effective contraceptive measures
  • Administration of another investigational agent within 6 weeks prior to start of IMP administration
  • Use of any of the prohibited medications and other substances listed in Appendix 3 CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP administration or a period of at least 5 times the respective elimination halflife, whichever is longer
  • Known severe gastrointestinal disorder, including malabsorption (at screening)
  • Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or pulmonary fibrosis* * If interstitial lung abnormalities, (e.g. ground-glass or linear opacity) are suspected on chest CT scan (high-resolution CT), regardless of whether or not there are any accompanying symptoms it must be confirmed, such as through consultation with a respiratory or radiology expert if necessary, that the patient dose not fall under this exclusion criterion before the patient can be enrolled in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: OPB-51602
Drug: OPB-51602
OPB-51602 at a dose of 2, 5, 10, 20, 40, 60, 80, or 100 mg/day,will be orally administered to subjects once daily for 2 weeks in each cycle of treatment in Dose Escalation Stage.A 2-day treatment-free interval will occur on Days 2 and 3 for PK sampling. Study drug administration will resume on Day 4 and continue until Day 17 in cycle 1.In Expansion stage part 1, OPB-51602 will be administered at recommend dose (4mg) for 3 weeks per cycle 9 2 weeks treatment and 1 week washout). There is also 2-day treatment free interval between Day 1 and Day 4 for PK sampling in cycle 1.In Expansion stage part 2, subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in Cycle 1. The same subjects will be treated at MTD(5mg)from cycle 2 onwards for 4 weeks per cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety and tolerability
Time Frame: 3 weeks
AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: duration of the treatment
plasma and urinary concentrations of OPB-51602 and its metabolites
duration of the treatment
safety and tolerability
Time Frame: duration of treatment
AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in all treatment cycles.
duration of treatment
efficacy
Time Frame: duration of treatment
Response and progression evaluated using Response Evaluation criteria in solid tumors (RECIST)
duration of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Beijing Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Goh Boon Cher, Dr, Department of Haematology-Oncology,National University Hospital
  • Principal Investigator: Daniel Tan shao Weng, MD, PhD, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 266-09-801-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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