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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042885
• Other study ID #: 314-12-401
• Secondary ID: 2013-001249-15
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 17, 2014
• Last updated: October 19, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2014
• Source: Otsuka Novel Products GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Squamous Cell
• Endometrial Cancer
• Ovarian Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Salivary Gland Cancer
• Squamous Cell Carcinoma of the Cervix
• Uterine Cervical Neoplasms

Intervention

Drug:
• OPB-111001

Locations

Country	Name	City	State
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	The Institute of Cancer Research, Royal Marsden NHS Foundation Trust	London, Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Novel Products GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose / Recommended Phase 2 dose; Tolerability		after 2 or 6 weeks depending on study part; continously	Yes
Secondary	Pharmacokinetic parameters for OPB-111001 and its metabolites	Frequent sampling during Cycle 1 to 3, D1 only from Cycle 4 onwards	repeatedly until end of study (average of 3 months assumed)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Time to treatment failure		At end of study (after average of 3 months assumed)	No