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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02909452
Other study ID # SNDX-275-0141
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 20, 2016
Est. completion date February 9, 2021

Study information

Verified date June 2018
Source Syndax Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to explore different dosing levels and schedules of entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy


Description:

This is a Phase 1, open-label, single center, randomized study to assess the safety and tolerability of 3 different dose regimens of entinostat in combination with pembrolizumab in patients with advanced solid tumors who previously completed Study SNDX-275-0140 (NCT02897778). Up to 30 patients will be randomized in a 1:1:1 fashion to one of three arms. In the event that greater than or equal to 2 out of the first 6 patients randomized experience a dose-limiting toxicity, the next patient randomized to that Arm will receive treatment at a reduced starting dose as outlined in the protocol.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 9, 2021
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Completed Study SNDX-275-0140 (NCT02897778) 2. Any AE or toxicity experienced in Study SNDX-275-0140 (NCT02897778) is resolved to less than or equal to Grade 1 3. Continues to meet inclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study Exclusion Criteria: 1. Completed Study SNDX-275-0140 (NCT02897778) more than 30 days prior to Cycle 1 Day 1 of this study 2. Continues to meet exclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time of entry into this study

Study Design


Intervention

Drug:
Entinostat
HDAC (histone deacetylase) inhibitor
Pembrolizumab
A selective humanized monoclonal antibody (mAb)

Locations

Country Name City State
United States The START Center for Cancer Care San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Syndax Pharmaceuticals Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ratio of effector T cells to regulatory T cells in blood pre-therapy and post-therapy Pre-dose through Cycle 3 Day 1
Other Changes in the number of circulating immune related cells Pre-dose through Cycle 3 Day 1
Other Changes in protein lysine acetylation in peripheral blood cells pre-therapy and post-therapy Pre-dose through Cycle 3 Day 1
Other Best overall tumor response Baseline up to 2 years
Primary Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) resulting in the permanent discontinuation of study drug, and deaths occurring within the reporting period required for the study Each treatment cycle is 21 days. All events will be collected from informed consent through 90 days post-last dose or through 30 days after initiation of new anti-cancer therapy
Primary Changes from baseline in laboratory results Baseline through 90 day safety follow-up visit
Primary Changes from baseline in vital signs Baseline through 90 day safety follow-up visit
Primary Changes from baseline in ECG results Baseline through 90 day safety follow-up visit
Secondary AUC0-t (area under the curve to last observed concentration time) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
Secondary AUC0-inf (area under the curve extrapolated to infinity) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
Secondary Cmax (maximum plasma concentration) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
Secondary Tmax (time to maximum plasma concentration) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
Secondary T1/2 (elimination half life) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
Secondary Vd (clearance and volume of distribution) of entinostat when given in combination with pembrolizumab Pre-dose through Cycle 3 Day 1
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