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

NCT ID: NCT02042885

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

Brief Summary

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

Conditions

Prostate Cancer; Salivary Gland Cancer; Endometrial Cancer; Squamous Cell Carcinoma of the Cervix; Breast Cancer; Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Regimen A Escalation

1: OPB-111001, orally, once weekly

Group Type: EXPERIMENTAL

OPB-111001

Intervention Type: DRUG

2: Regimen A Extension

2: OPB-111001, orally, once weekly

Group Type: EXPERIMENTAL

OPB-111001

Intervention Type: DRUG

3: Regimen B Escalation

3: OPB-111001, orally, 2 - 3 times per week

Group Type: EXPERIMENTAL

OPB-111001

Intervention Type: DRUG

4: Regimen B Extension

4: OPB-111001, orally, 2 - 3 times per week

Group Type: EXPERIMENTAL

OPB-111001

Intervention Type: DRUG

Interventions

OPB-111001

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Novel Products GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johann De Bono, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

The Institute of Cancer Research, Royal Marsden NHS Foundation Trust London United Kingdom

Sarah Blagden, Dr.

Role: PRINCIPAL_INVESTIGATOR

NIHR/Wellcome Trust Imperial CRF, Imperial College Healthcare NHS Trust, Imperial Center for Translational and Experimental Medicine (L-Block), Hammersmith Hospital London, United Kingdom

Locations

The Institute of Cancer Research, Royal Marsden NHS Foundation Trust

London, Sutton, Surrey, United Kingdom

NIHR/Wellcome Trust Imperial CRF/Imperial College Healthcare NHS Trust, Imperial Centre for Translational and Experimental Medicine (L-Block), Hammersmith Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2013-001249-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

314-12-401

Identifier Type: -

Identifier Source: org_study_id