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

NCT02042885 | Terminated Phase 1 DMC

• 2 other identifiers: 314-12-4012013-001249-15
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose / Recommended Phase 2 dose; Tolerability

  after 2 or 6 weeks depending on study part; continously

Secondary Outcomes (5)

• Pharmacokinetic parameters for OPB-111001 and its metabolites

  repeatedly until end of study (average of 3 months assumed)

• Assessment of antitumor activity as defined by Response Evaluation Criteria in Solid Tumours (RECIST)

  repeatedly every 8th week until end of study (average of 3 months assumed)

• Prostate-specific antigen (PSA) response in patients with prostate cancer

  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

  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

  At end of study (after average of 3 months assumed)

Study Arms (4)

1: Regimen A Escalation

EXPERIMENTAL

1: OPB-111001, orally, once weekly

Drug: OPB-111001

2: Regimen A Extension

EXPERIMENTAL

2: OPB-111001, orally, once weekly

Drug: OPB-111001

3: Regimen B Escalation

EXPERIMENTAL

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

Drug: OPB-111001

4: Regimen B Extension

EXPERIMENTAL

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

Drug: OPB-111001

Interventions

OPB-111001 DRUG

1: Regimen A Escalation; 2: Regimen A Extension; 3: Regimen B Escalation; 4: Regimen B Extension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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:
• Dosing was changed within 6 weeks before Screening or
• 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.

Sponsors & Collaborators

• Otsuka Novel Products GmbH: lead

Study Sites (2)

The Institute of Cancer Research, Royal Marsden NHS Foundation Trust

London, Sutton, Surrey, SM2 5PT, United Kingdom

Location

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

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Salivary Gland Neoplasms; Endometrial Neoplasms; Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2014-07

Locations

GB (2)