A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:December 2016
End Date:June 2019
Contact:Zenith Study Team
Email:ZEN003694-002@zenithepigenetics.com

Use our guide to learn which trials are right for you!

A Phase 1b/2a Safety and Tolerability Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

This is an open label, non-randomized, Phase 1b/2a, dose escalation and dose confirmation
study of ZEN003694 in combination with enzalutamide in patients with mCRPC.


Inclusion Criteria:

1. Males age ≥ 18 years

2. Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically
castrated or continuous medical castration for ≥ 8 weeks prior to screening

3. Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of
study drug

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Adequate laboratory parameters [absolute neutrophil (ANC), platelets, asparate
aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine
and coagulation parameters] at screening

6. Dose Escalation only: Enzalutamide-naïve patients following prior progression on
abiraterone by PCWG2 criteria and within 12 weeks of discontinuing abiraterone

7. Dose Confirmation Cohort A (DC-A) only: Currently receiving enzalutamide as most
recent systemic therapy for mCRPC and have experienced PSA progression by PCWG2
criteria in the absence of radiographic and/or clinical progression. Patients may or
may not have experienced prior progression on abiraterone.

8. Dose Confirmation Cohort B (DC-B) only: Enzalutamide-naïve patients following prior
progression on abiraterone by PCWG2 criteria and within 12 weeks of discontinuing
abiraterone

Exclusion Criteria:

1. Any history of brain metastases or prior seizure or conditions predisposing to seizure
activity

2. Have previously received an investigational BET inhibitor (including previous
participation in this study or Study ZEN003694-001)

3. Have received prior systemic anti-cancer therapy (including abiraterone) or
investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior
to the first administration of study drug

4. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy
(excluding alopecia and neuropathy) prior to study entry

5. Radiation therapy within 2 weeks of the first administration of study drug

6. 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)

7. Have received prior investigational anti-androgen therapy, including ARN-509

8. Currently receiving medications known to be strong inhibitors of CYP2C8, strong
inducers (except enzalutamide) or inhibitors of CYP3A4 and substrates of CYP3A4,
CYP2C9 and CYP2C19 with a narrow therapeutic window. Strong inducers, inhibitors and
substrates must be discontinued at least 7 days prior to the first administration of
study drug.

9. Not a candidate for enzalutamide treatment, in the opinion of the Investigator
We found this trial at
8
sites
?
mi
from
New York, NY
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials