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NCT03192111
A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function
Phase 1 trial testing Entinostat in Renal Impairment in 40 participants. Completed in 23 November 2017.
23 November 2017
Quick facts
| Lead sponsor | Syndax Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 27 July 2017 |
| Primary completion | 23 November 2017 |
| Estimated completion | 23 November 2017 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Entinostat — full drug profile →
Conditions studied
- Renal Impairment — all drugs for Renal Impairment →
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Syndax Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Renal Impairment or Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment. The primary objective of this study is to evaluate the pharmacokinetics of a single dose of entinostat in adult subjects with mild, moderate and severe renal impairment compared to healthy mean-matched subjects. The secondary objective of this study is to evaluate the safety and tolerability of entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy mean-matched adult subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Reviewing the role of healthy volunteer studies in drug development.
Karakunnel JJ, Bui N, Palaniappan L, Schmidt KT, et al · · 2018 · cited 33× · PMID 30509294 · DOI 10.1186/s12967-018-1710-5
Verify or expand the search:
- PubMed search for NCT03192111
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Entinostat
Trials testing the same drug.
- NCT07441486 — A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment · Phase 2 · not yet recruiting
- NCT07261592 — Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT05898828 — Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Th · Phase 1, PHASE2 · withdrawn
- NCT05053971 — Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Renal Impairment
Currently open trials in the same condition.
- NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
- NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
- NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
- NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
- NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting
Other Syndax Pharmaceuticals trials
Trials by the same sponsor.
- NCT05731947 — Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors · Phase 1, PHASE2 · completed
- NCT05406817 — Study of Radiolabeled Revumenib in Adults With Acute Leukemia · Phase 1 · completed
- NCT05326516 — A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia · Phase 1 · completed
- NCT04415073 — A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 · Phase 2 · terminated
- NCT04065399 — A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03192111 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Syndax Pharmaceuticals
- Last refreshed: 13 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03192111.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing