A Clinical Trial to Determine the Most Suitable Dose of OPB-111001 in Patients With Advanced Cancer

October 19, 2015 updated by: Otsuka Novel Products GmbH

A Two-part Phase 1/2a, Open-label, Dose Escalation Study to Evaluate the Tolerability and Preliminary Antitumour Activity of OPB-111001 in Patients With Advanced Cancers That Are Poorly Responsive to Standard Anticancer Treatment

The purpose of this study is to determine the tolerability profile of OPB-111001 and to determine the most suitable dose of OPB-111001 in patients with advanced cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

79

Phase

  • Phase 2
  • 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

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • NIHR/Wellcome Trust Imperial CRF/Imperial College Healthcare NHS Trust, Imperial Centre for Translational and Experimental Medicine (L-Block), Hammersmith Hospital
    • Surrey
      • London, Sutton, Surrey, United Kingdom, SM2 5PT
        • The Institute of Cancer Research, Royal Marsden NHS Foundation Trust

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Patients with prostate cancer that is recurrent or did not respond to previous hormone therapy and/or who have exhausted standard treatment options.

For the dose escalation parts only:

Patients who have exhausted standard treatment options with recurrent or refractory cancer (ovarian cancer, cervical squamous cell carcinoma, breast cancer, salivary gland cancer, endometrial cancer)

  • Histologically or cytologically documented diagnosis of cancer
  • Measurable disease according to RECIST Version 1.1 or for prostate cancer also evaluable disease according to Prostate Cancer Working Group 2 (PCWG2) eligibility criteria or for ovarian cancer also evaluable disease (non-measurable) according to Gynaecologic Cancer Intergroup (GCIG) criteria
  • Absolute neutrophil count ≥1.5 (1500/mm3) and platelets ≥100 × 109/L (without platelet transfusion within the last 4 weeks before first study drug administration), and haemoglobin ≥9 g/dL at Screening
  • Alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal (ULN), Total bilirubin ≤1.5 × ULN (exception: patients with liver metastasis are allowed to have aspartate aminotransferase ≤5 × ULN and alanine aminotransferase ≤5 × ULN) at screening
  • Albumin ≥26 g/L at Screening

Exclusion Criteria:

  • Concurrent prior treatment-related toxicity of Grade 2 or higher. Exception: any toxicity that is in the view of the investigator not a clinically significant safety risk for Investigational medicinal product (IMP) administration.
  • Previous treatment with cytotoxic chemotherapy or other anticancer therapy within 4 weeks before the first dosing with study drug (at least 6 weeks for mitoxantrone, nitrosurea, and bicalutamide).

  • Treatment with systemic glucocorticosteroids of more than a 2 mg dexamethasone equivalent per day or in cases of treatment with ≤2 mg dexamethasone equivalent per day:

    1. Dosing was changed within 6 weeks before Screening or
    2. The patient's cancer is responding to glucocorticosteroid intake
  • Radiation therapy within 4 weeks prior to the first dosing with IMP.
  • Treatment with a systemic IMP in a clinical trial within 28 days before the Screening Visit.
  • Current or past history of clinically significant gastrointestinal disease or major gastrointestinal surgery, malabsorption syndrome, or other conditions that could interfere with enteral absorption.
  • Concurrent clinically significant unrelated systemic illness (e.g., serious infection) or significant pulmonary, hepatic, or other organ dysfunction that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results.

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: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Regimen A Escalation
1: OPB-111001, orally, once weekly
Drug: OPB-111001
Experimental: 2: Regimen A Extension
2: OPB-111001, orally, once weekly
Drug: OPB-111001
Experimental: 3: Regimen B Escalation
3: OPB-111001, orally, 2 - 3 times per week
Drug: OPB-111001
Experimental: 4: Regimen B Extension
4: OPB-111001, orally, 2 - 3 times per week
Drug: OPB-111001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose / Recommended Phase 2 dose; Tolerability
Time Frame: after 2 or 6 weeks depending on study part; continously
after 2 or 6 weeks depending on study part; continously

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters for OPB-111001 and its metabolites
Time Frame: repeatedly until end of study (average of 3 months assumed)
Frequent sampling during Cycle 1 to 3, D1 only from Cycle 4 onwards
repeatedly until end of study (average of 3 months assumed)
Assessment of antitumor activity as defined by Response Evaluation Criteria in Solid Tumours (RECIST)
Time Frame: repeatedly every 8th week until end of study (average of 3 months assumed)
repeatedly every 8th week until end of study (average of 3 months assumed)
Prostate-specific antigen (PSA) response in patients with prostate cancer
Time Frame: repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
Cancer antigen 125 (CA 125) response in patients with ovarian cancer
Time Frame: repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
repeatedly (Cycle 1 to 3 on Day 1, then every 4th week) until end of study (average of 3 months assumed)
Time to treatment failure
Time Frame: At end of study (after average of 3 months assumed)
At end of study (after average of 3 months assumed)

Collaborators and Investigators

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

Sponsor

Otsuka Novel Products GmbH

Investigators

  • Principal Investigator: Johann De Bono, Prof. Dr., The Institute of Cancer Research, Royal Marsden NHS Foundation Trust London United Kingdom
  • Principal Investigator: Sarah Blagden, Dr., NIHR/Wellcome Trust Imperial CRF, Imperial College Healthcare NHS Trust, Imperial Center for Translational and Experimental Medicine (L-Block), Hammersmith Hospital London, United Kingdom

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

January 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 314-12-401
  • 2013-001249-15 (EudraCT Number)

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.

Clinical Trials on Breast Cancer

Clinical Trials on OPB-111001

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe