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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Otsuka Novel Products GmbH
Sponsor:
Information provided by (Responsible Party):
Otsuka Novel Products GmbH
ClinicalTrials.gov Identifier:
NCT02042885
First received: January 17, 2014
Last updated: July 18, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety Study
Masking: 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 ] [ Designated as safety issue: Yes ]
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Secondary Outcome Measures:
  • Pharmacokinetic parameters for OPB-111001 and its metabolites [ Time Frame: repeatedly until end of study (average of 3 months assumed) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    --

  • 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) ] [ Designated as safety issue: No ]
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  • 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) ] [ Designated as safety issue: No ]
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  • Time to treatment failure [ Time Frame: At end of study (after average of 3 months assumed) ] [ Designated as safety issue: No ]
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Estimated Enrollment: 79
Study Start Date: January 2014
Estimated Primary Completion Date: December 2016 (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
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Other Name: ---
Experimental: 2: Regimen A Extension
2: OPB-111001, orally, once weekly
Drug: OPB-111001
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Other Name: ---
Experimental: 3: Regimen B Escalation
3: OPB-111001, orally, 2 - 3 times per week
Drug: OPB-111001
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Other Name: ---
Experimental: 4: Regimen B Extension
4: OPB-111001, orally, 2 - 3 times per week
Drug: OPB-111001
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Other Name: ---

Detailed Description:

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042885

Contacts
Contact: Jutta Amersdorffer, Dr. +49 (0) 89 2060205-00 clinicaltrial-314-12-401@otsuka.de

Locations
United Kingdom
The Institute of Cancer Research, Royal Marsden NHS Foundation Trust Recruiting
London, Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Sonia Serrano    +44 (0) 208722 4087    sonia.serrano@icr.ac.uk   
NIHR/Wellcome Trust Imperial CRF/Imperial College Healthcare NHS Trust, Imperial Centre for Translational and Experimental Medicine (L-Block), Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Tom Cole, PhD    +44 (0) 203 313 6198    t.cole@imperial.ac.uk   
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

No publications provided

Responsible Party: Otsuka Novel Products GmbH
ClinicalTrials.gov Identifier: NCT02042885     History of Changes
Other Study ID Numbers: 314-12-401, 2013-001249-15
Study First Received: January 17, 2014
Last Updated: July 18, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Otsuka Novel Products GmbH:
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Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Squamous Cell
Ovarian Neoplasms
Breast Neoplasms
Uterine Cervical 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
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Breast Diseases
Skin Diseases
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on October 01, 2014