Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03829930|
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma||Drug: Entinostat Drug: Enzalutamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||3+3 Design|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2024|
Experimental: Entinostat and Enzalutamide
Entinostat and Enzalutamide
Entinostat is formulated for oral administration. A food effect is evident for entinostat; exposure is significantly reduced when entinostat is administered with a high fat meal. Accordingly, entinostat is to be administered on an empty stomach, at least 1 hour before and 2 hours after a meal. Entinostat tablets should not be split, crushed, or chewed. Consult the individual clinical protocols for specific dosing instructions.
Dose level 1: 3mg PO weekly. Dose level 2: 5mg PO weekly.
Other Name: SYND-275 amd MS-275
Dose level 1: 160 mg PO daily. Dose level 2: 160 mg PO daily.
Other Name: MDV3100
- Determination of a suitable dose of Entinostat in combination with Enzalutamide [ Time Frame: 18 months ]Number of participants who experience an adverse event assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Progression Free Survival [ Time Frame: 3 years ]Number of participants who survive without disease progression
- Changes in circulating T cell subtype, peripheral blood mononuclear cell (PBMC) H3 acetylation, and phenotype of circulating Tregs [ Time Frame: 18 months ]Analysis of immunomodulatory effects of Entinostat
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829930
|Contact: Brittany McNamara, BS||(202)firstname.lastname@example.org|
|Principal Investigator:||Jianquig Lin, MD||George Washington Cancer Center|