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

January 17, 2014
July 18, 2014
January 2014
December 2016   (final data collection date for primary outcome measure)
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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Same as current
Complete list of historical versions of study NCT02042885 on ClinicalTrials.gov Archive Site
  • 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 ]
    ---
  • 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 ]
    ---
  • Time to treatment failure [ Time Frame: At end of study (after average of 3 months assumed) ] [ Designated as safety issue: No ]
    ---
Same as current
Not Provided
Not Provided
 
A Clinical Trial to Determine the Most Suitable Dose of OPB-111001 in Patients With Advanced Cancer
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

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Salivary Gland Cancer
  • Endometrial Cancer
  • Squamous Cell Carcinoma of the Cervix
  • Breast Cancer
  • Ovarian Cancer
Drug: OPB-111001
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Other Name: ---
  • Experimental: 1: Regimen A Escalation
    1: OPB-111001, orally, once weekly
    Intervention: Drug: OPB-111001
  • Experimental: 2: Regimen A Extension
    2: OPB-111001, orally, once weekly
    Intervention: Drug: OPB-111001
  • Experimental: 3: Regimen B Escalation
    3: OPB-111001, orally, 2 - 3 times per week
    Intervention: Drug: OPB-111001
  • Experimental: 4: Regimen B Extension
    4: OPB-111001, orally, 2 - 3 times per week
    Intervention: Drug: OPB-111001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
79
Not Provided
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jutta Amersdorffer, Dr. +49 (0) 89 2060205-00 clinicaltrial-314-12-401@otsuka.de
United Kingdom
 
NCT02042885
314-12-401, 2013-001249-15
Yes
Otsuka Novel Products GmbH
Otsuka Novel Products GmbH
Not Provided
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
Otsuka Novel Products GmbH
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP