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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02042885
First Posted: January 23, 2014
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Novel Products GmbH
  Purpose
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

Condition Intervention Phase
Prostate Cancer Salivary Gland Cancer Endometrial Cancer Squamous Cell Carcinoma of the Cervix Breast Cancer Ovarian Cancer Drug: OPB-111001 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Novel Products GmbH:

Primary Outcome Measures:
  • Maximum tolerated dose / Recommended Phase 2 dose; Tolerability [ Time Frame: after 2 or 6 weeks depending on study part; continously ]

Secondary Outcome Measures:
  • 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

  • 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) ]
  • 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) ]
  • 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) ]
  • Time to treatment failure [ Time Frame: At end of study (after average of 3 months assumed) ]

Estimated Enrollment: 79
Study Start Date: January 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042885


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

Responsible Party: Otsuka Novel Products GmbH
ClinicalTrials.gov Identifier: NCT02042885     History of Changes
Other Study ID Numbers: 314-12-401
2013-001249-15 ( EudraCT Number )
First Submitted: January 17, 2014
First Posted: January 23, 2014
Last Update Posted: October 20, 2015
Last Verified: July 2014

Keywords provided by Otsuka Novel Products GmbH:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Squamous Cell
Endometrial Neoplasms
Salivary Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Mouth Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases