Metastatic Castration-Resistant Prostate CancerPhase 1NCT02705469
A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing ZEN003694 in people with Metastatic Castration-Resistant Prostate Cancer, run by Zenith Epigenetics at 8 sites in United States.
Trial summary
This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- ZEN003694
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2016to Oct 2017
- Phase
- Phase 1
- 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
Who may be able to join
- Males age ≥ 18 years
- Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
- Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
- Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate laboratory parameters [absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening
Who cannot join
- Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
- Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- Radiation therapy within 2 weeks of first administration of study drug
- Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
- Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Karmanos Cancer Institute
Detroit, Michigan
Karmanos Cancer Institute
Farmington Hills, Michigan
Virginia Oncology Associates
Hampton, Virginia
University of California Los Angeles Medical Center
Los Angeles, California
Memorial Sloan Kettering Cancer Center
New York, New York
Virginia Oncology Associates
Norfolk, Virginia
Oregon Health & Science University
Portland, Oregon
University of California San Francisco Medical Center
San Francisco, California
About this study
Official title: A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.
- Being tested
- ZEN003694
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (mCRPC), Phase 1, Prostate Cancer, Pharmacokinetics (PK), ZEN003694, ZEN-3694, Metastatic Castrate-Resistant Prostate Cancer, BET inhibitor (BETi), Bromodomain, Pharmacodynamics (PD), Epigenetics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEN003694Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Dose Confirmation - ZEN003694 Single Agent | Experimental | ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients. Receives: Drug: ZEN003694 |
What is being measured
The primary outcome is the main question the study is designed to answer.
For dose escalation only: Incidence of dose-limiting toxicities (DLT)
A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).
Measured: Cycle 1 (Day 1 thru Day 28)
For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
Measured: Up to 24 months
Secondary outcomes (9)
Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694
AUC is defined as the area under the curve (plasma concentration of drug over time).
Measured: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Cmax of ZEN003694
Cmax is defined as maximum or peak plasma concentration of drug.
Measured: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Cmin of ZEN003694
Cmin is defined as minimum or trough plasma concentration of drug.
Measured: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Tmax of ZEN003694
Tmax is defined as the time from dosing to the maximum plasma concentration.
Measured: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: t1/2 of ZEN003694
t/12 is defined as the half-life of drug.
Measured: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria
Measured: From screening up to 24 months
Evaluate radiographic response rate by PCWG2 criteria
Measured: From screening up to 24 months
Evaluate median progression-free survival by PCWG2 criteria
Measured: From screening up to 24 months
Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only
Measured: From screening up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenith Epigenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705469
- Sponsor's protocol ID
- ZEN003694-001
- Status last verified
- Nov 2017
- First submitted
- 10 Feb 2016
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02705469
- Acronym / sponsor ID
- ZEN003694-001
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (mCRPC), Phase 1, Prostate Cancer, Pharmacokinetics (PK), ZEN003694, ZEN-3694, Metastatic Castrate-Resistant Prostate Cancer, BET inhibitor (BETi)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Zenith EpigeneticsIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 Mar 2016 (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.
This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Dose Confirmation - ZEN003694 Single Agent | Experimental | Drug: ZEN003694ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males age ≥ 18 years
- Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
- Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
- Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (7 listed)
- Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
- Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- Radiation therapy within 2 weeks of first administration of study drug
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 |
|---|---|---|
| ZEN003694 | Drug | Dose Escalation and Dose Confirmation - ZEN003694 Single Agent |
Primary outcome
For dose escalation only: Incidence of dose-limiting toxicities (DLT)
Time frame: Cycle 1 (Day 1 thru Day 28)
A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).
For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
Time frame: Up to 24 months
9 secondary outcomes
Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694
Time frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Cmax of ZEN003694
Time frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Cmin of ZEN003694
Time frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: Tmax of ZEN003694
Time frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Measure the PK parameter: t1/2 of ZEN003694
Time frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose
Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria
Time frame: From screening up to 24 months
Evaluate radiographic response rate by PCWG2 criteria
Time frame: From screening up to 24 months
Evaluate median progression-free survival by PCWG2 criteria
Time frame: From screening up to 24 months
Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only
Time frame: From screening up to 12 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 20 Nov 2017.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZEN003694 in people with Metastatic Castration-Resistant Prostate Cancer, run by Zenith Epigenetics at 8 sites 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?
The sponsor lists 6 inclusion and 7 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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.
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?
For dose escalation only: Incidence of dose-limiting toxicities (DLT) (time frame: Cycle 1 (Day 1 thru Day 28)). The study lists 2 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 20 Nov 2017.