Prostate CancerPhase 2NCT02130700
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
A Phase 2 study testing VT-464: given orally twice daily in 28-day cycles and VT-464: given orally once daily in 28-day cycles in people with Prostate Cancer, run by Innocrin Pharmaceutical at 1 site in United States.
Trial summary
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- VT-464: given orally twice daily in 28-day cycles and VT-464: given orally once daily in 28-day cycles
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Nov 2017
- Phase
- Phase 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
- Men only
- No healthy volunteers
- Adult, Older adult
Key Eligibility Criteria:
- Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
- Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on GnRH agonists or antagonists.
- All patients in this trial must have been treated with enzalutamide.
- Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients in Cohort 2 must have received one (and not more) prior course of chemotherapy for mCRPC.
- Progression must be evidenced and documented by any of the following parameters:
- PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination
- Appearance of one or more new lesions on bone scan
- Progressive measurable disease by RECIST 1.1
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health, National Cancer Institute
Bethesda, Maryland, 20892
About this study
Official title: A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of VT-464 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Previously Been Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.
Read the detailed description
This is a Phase 2 open-label study of VT-464 in patients with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide, female patients with triple negative, AR positive breast cancer and men with ER positive breast cancer. The study consists of five cohorts: patients in Cohort 1 must have never received prior chemotherapy. Patients in Cohort 2 must have received at least one (and not more) prior course of chemotherapy for CRPC. Women with TNBC will be stratified into two cohorts AR 1 to 9% (cohort 3) and AR > 10% (cohort 4). Cohort 5 will consist of men who have been diagnosed with ER+ breast cancer and have failed at least one prior endocrine therapy.
- Conditions
- Prostate Cancer
- Being tested
- VT-464: given orally twice daily in 28-day cycles, VT-464: given orally once daily in 28-day cycles
- Keywords
- mCRPC, metastatic, castration-resistant prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-464: given orally twice daily in 28-day cyclesDrug
Also called VT-464
Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose
VT-464: given orally once daily in 28-day cyclesDrug
Also called seviteronel
Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-Naive Patients | Experimental | VT-464: given orally twice daily in 28-day cycles Receives: Drug: VT-464: given orally twice daily in 28-day cycles |
| Previous Chemotherapy Patients | Experimental | VT-464: given orally twice daily in 28-day cycles Receives: Drug: VT-464: given orally twice daily in 28-day cycles |
| AR Positive 1 - 9% TNBC | Experimental | VT-464: given orally once daily in 28-day cycles Receives: Drug: VT-464: given orally once daily in 28-day cycles |
| Male ER Positive | Experimental | VT-464: given orally once daily in 28-day cycles Receives: Drug: VT-464: given orally once daily in 28-day cycles |
| AR Positive >10% TNBC | Experimental | VT-464: given orally once daily in 28-day cycles Receives: Drug: VT-464: given orally once daily in 28-day cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
To determine the PSA response as defined by a ≥ 50% decrease in serum PSA per the Prostate Cancer Clinical Trials Working Group 2 criteria after each cycle and after 12 weeks of dosing with VT-464 compared to PSA level at baseline in patients who have been previously treated with enzalutamide.
Measured: 12 weeks
Progression-free survival using Kaplan-Meier curves
Kaplan-Meier curves of progression-free survival (PFS) will be constructed in each cohort and the median PFS will be determined and informally compared to any available results.
Measured: 8 months
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Measured: 16 weeks
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Measured: 24 weeks
Secondary outcomes (3)
Overall survival using Kaplan-Meier curves
Overall Survival: will be analyzed similarly to PFS, with a separate Kaplan-Meier curve for each arm. A patient for whom there is no death event will be censored; the censored date will be the date of last contact.
Measured: 32 months
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
The safety of VT-464 will be evaluated by laboratory evaluation, electrocardiogram, the report of adverse events and concomitant medications at each 28-day cycle of treatment and 4-5 weeks after therapy has been discontinued.
Measured: 8 months
Maximum PSA response compared to baseline
Maximum PSA response will be descriptive in nature and presented for each cohort as a percent of patients and as a waterfall plot.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionNov 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocrin Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130700
- Sponsor's protocol ID
- INO-VT-464-CL-002
- Other IDs
- VMT-VT-464-CL-002
- Status last verified
- May 2018
- First submitted
- 22 Apr 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of VT-464 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Previously Been Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02130700
- Acronym / sponsor ID
- INO-VT-464-CL-002
- Conditions
- Prostate Cancer
- Keywords
- mCRPC, metastatic, castration-resistant prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Innocrin PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 5 May 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 goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.
Detailed description
This is a Phase 2 open-label study of VT-464 in patients with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide, female patients with triple negative, AR positive breast cancer and men with ER positive breast cancer. The study consists of five cohorts: patients in Cohort 1 must have never received prior chemotherapy. Patients in Cohort 2 must have received at least one (and not more) prior course of chemotherapy for CRPC. Women with TNBC will be stratified into two cohorts AR 1 to 9% (cohort 3) and AR > 10% (cohort 4). Cohort 5 will consist of men who have been diagnosed with ER+ breast cancer and have failed at least one prior endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-Naive Patients | Experimental | Drug: VT-464: given orally twice daily in 28-day cyclesVT-464: given orally twice daily in 28-day cycles |
| Previous Chemotherapy Patients | Experimental | Drug: VT-464: given orally twice daily in 28-day cyclesVT-464: given orally twice daily in 28-day cycles |
| AR Positive 1 - 9% TNBC | Experimental | Drug: VT-464: given orally once daily in 28-day cyclesVT-464: given orally once daily in 28-day cycles |
| Male ER Positive | Experimental | Drug: VT-464: given orally once daily in 28-day cyclesVT-464: given orally once daily in 28-day cycles |
| AR Positive >10% TNBC | Experimental | Drug: VT-464: given orally once daily in 28-day cyclesVT-464: given orally once daily in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| VT-464: given orally twice daily in 28-day cyclesAlso: VT-464Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose | Drug | Chemotherapy-Naive Patients, Previous Chemotherapy Patients |
| VT-464: given orally once daily in 28-day cyclesAlso: seviteronelOral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose | Drug | AR Positive 1 - 9% TNBC, AR Positive >10% TNBC, Male ER Positive |
Primary outcome
The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
Time frame: 12 weeks
To determine the PSA response as defined by a ≥ 50% decrease in serum PSA per the Prostate Cancer Clinical Trials Working Group 2 criteria after each cycle and after 12 weeks of dosing with VT-464 compared to PSA level at baseline in patients who have been previously treated with enzalutamide.
Progression-free survival using Kaplan-Meier curves
Time frame: 8 months
Kaplan-Meier curves of progression-free survival (PFS) will be constructed in each cohort and the median PFS will be determined and informally compared to any available results.
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Time frame: 16 weeks
Clinical benefit rate will be measured at designated timepoints as listed per protocol
Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer
Time frame: 24 weeks
Clinical benefit rate will be measured at designated timepoints as listed per protocol
3 secondary outcomes
Overall survival using Kaplan-Meier curves
Time frame: 32 months
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Time frame: 8 months
Maximum PSA response compared to baseline
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-464: given orally twice daily in 28-day cycles and VT-464: given orally once daily in 28-day cycles in people with Prostate Cancer, run by Innocrin Pharmaceutical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464 (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 7 May 2018.