Prostate CancerPhase 1/2NCT02042885
A Clinical Trial to Determine the Most Suitable Dose of OPB-111001 in Patients With Advanced Cancer
A Phase 1/2 study testing OPB-111001 in people with Prostate Cancer and Salivary Gland Cancer, run by Otsuka Novel Products GmbH at 2 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Salivary Gland Cancer, Endometrial Cancer
- What is being tested?
- OPB-111001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2014to Feb 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NIHR/Wellcome Trust Imperial CRF/Imperial College Healthcare NHS Trust, Imperial Centre for Translational and Experimental Medicine (L-Block), Hammersmith Hospital
London, W12 0HS
The Institute of Cancer Research, Royal Marsden NHS Foundation Trust
London, Sutton, Surrey, SM2 5PT
About this study
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
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
- Being tested
- OPB-111001
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Salivary Gland Neoplasms, Endometrial Neoplasms, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-111001Drug
| Study group | Role | What they receive |
|---|---|---|
| 1: Regimen A Escalation | Experimental | 1: OPB-111001, orally, once weekly Receives: Drug: OPB-111001 |
| 2: Regimen A Extension | Experimental | 2: OPB-111001, orally, once weekly Receives: Drug: OPB-111001 |
| 3: Regimen B Escalation | Experimental | 3: OPB-111001, orally, 2 - 3 times per week Receives: Drug: OPB-111001 |
| 4: Regimen B Extension | Experimental | 4: OPB-111001, orally, 2 - 3 times per week Receives: Drug: OPB-111001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose / Recommended Phase 2 dose; Tolerability
Measured: after 2 or 6 weeks depending on study part; continously
Secondary outcomes (5)
Pharmacokinetic parameters for OPB-111001 and its metabolites
Frequent sampling during Cycle 1 to 3, D1 only from Cycle 4 onwards
Measured: repeatedly until end of study (average of 3 months assumed)
Assessment of antitumor activity as defined by Response Evaluation Criteria in Solid Tumours (RECIST)
Measured: repeatedly every 8th week until end of study (average of 3 months assumed)
Prostate-specific antigen (PSA) response in patients with prostate cancer
Measured: 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
Measured: 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
Measured: At end of study (after average of 3 months assumed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Novel Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johann De Bono, Prof. Dr., Principal investigator, The Institute of Cancer Research, Royal Marsden NHS Foundation Trust London United KingdomSarah Blagden, Dr., 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042885
- Sponsor's protocol ID
- 314-12-401
- Other IDs
- 2013-001249-15
- Status last verified
- Jul 2014
- First submitted
- 17 Jan 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02042885
- Acronym / sponsor ID
- 314-12-401
- Conditions
- Prostate Cancer, Salivary Gland Cancer, Endometrial Cancer, Squamous Cell Carcinoma of the Cervix, Breast Cancer, Ovarian Cancer
- Keywords
- Prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Otsuka Novel Products GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Regimen A Escalation | Experimental | Drug: OPB-1110011: OPB-111001, orally, once weekly |
| 2: Regimen A Extension | Experimental | Drug: OPB-1110012: OPB-111001, orally, once weekly |
| 3: Regimen B Escalation | Experimental | Drug: OPB-1110013: OPB-111001, orally, 2 - 3 times per week |
| 4: Regimen B Extension | Experimental | Drug: OPB-1110014: OPB-111001, orally, 2 - 3 times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 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.
- 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
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPB-111001 | Drug | 1: Regimen A Escalation, 2: Regimen A Extension, 3: Regimen B Escalation, 4: Regimen B Extension |
Primary outcome
Maximum tolerated dose / Recommended Phase 2 dose; Tolerability
Time frame: after 2 or 6 weeks depending on study part; continously
5 secondary outcomes
Pharmacokinetic parameters for OPB-111001 and its metabolites
Time frame: repeatedly until end of study (average of 3 months assumed)
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)
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)
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)
Time to treatment failure
Time frame: At end of study (after average of 3 months assumed)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann De Bono, Prof. Dr. principal investigator
The Institute of Cancer Research, Royal Marsden NHS Foundation Trust London United Kingdom
Sarah Blagden, Dr. 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OPB-111001 in people with Prostate Cancer and Salivary Gland Cancer, run by Otsuka Novel Products GmbH at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose / Recommended Phase 2 dose; Tolerability (time frame: after 2 or 6 weeks depending on study part; continously). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.