NCT01317927 is a Phase 1 clinical trial of Belinostat, Warfarin in Solid Tumor, sponsored by Spectrum Pharmaceuticals, Inc.

Who is sponsoring NCT01317927?

NCT01317927 is sponsored by Spectrum Pharmaceuticals, Inc.

What drugs are being tested in NCT01317927?

Interventions in NCT01317927: Belinostat, Warfarin.

What condition does NCT01317927 study?

NCT01317927 studies Solid Tumor, Hematological Malignancy.

Is NCT01317927 still recruiting?

NCT01317927 is currently completed. Last updated 21 September 2015.

Last reviewed 2015-09-21 · How we verify

NCT01317927

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies

Completed Phase 1 Last updated 21 September 2015

What this trial tests

Phase 1 trial testing Belinostat, Warfarin in Solid Tumor in 27 participants. Completed in 1 June 2015.

Timeline

1 December 2010

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Spectrum Pharmaceuticals, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 December 2010
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

Belinostat, Warfarin — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
Hematological Malignancy — all drugs for Hematological Malignancy →

Sponsor

Spectrum Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Hematological Malignancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plasma concentration and pharmacodynamic effects of warfarin
Time frame: 34 days
Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
Pharmacokinetic evaluation of belinostat
Time frame: 34 days
Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg

Sponsor's own description

The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m². Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
The Roles of Histone Deacetylases and Their Inhibitors in Cancer Therapy.
Li G, Tian Y, Zhu WG. · · 2020 · cited 246× · PMID 33117804 · DOI 10.3389/fcell.2020.576946
Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
Targeting Histone Deacetylases in Diseases: Where Are We?
Benedetti R, Conte M, Altucci L. · · 2015 · cited 91× · PMID 24382114 · DOI 10.1089/ars.2013.5776

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Spectrum Pharmaceuticals, Inc trials

Trials by the same sponsor.

NCT05378763 — A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 2 · Phase 3 · suspended
NCT04981704 — A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacok · Phase 1 · completed
NCT04402008 — Study of Poziotinib in Japanese Patients With NSCLC · Phase 1, PHASE2 · terminated
NCT04436562 — Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects · Phase 1 · completed
NCT04187898 — Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01317927 (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 Spectrum Pharmaceuticals, Inc
Last refreshed: 21 September 2015

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/NCT01317927.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing