Clinical trial · Interventional
A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
NCT01317927CI-TRIAL-00019181completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat, Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Warfarin, Belinostat
- description
- Warfarin 5 mg po will be given on Day -14 and Day 3. Belinostat 1000 mg/m² will be given as a 30 minute IV infusion on Days 1 - 5
- interventionNames
- Drug: Belinostat, Warfarin
Primary outcomes (2)
- measure
- Plasma concentration and pharmacodynamic effects of warfarin
- timeFrame
- 34 days
- description
- Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
- measure
- Pharmacokinetic evaluation of belinostat
- timeFrame
- 34 days
- description
- Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Histological or cytological confirmed diagnosis of malignant disease * Age ≥18 years old * Adequate organ function * ECOG 0-2 * Estimated life expectancy \>3months * Negative pregnancy test for women of child bearing potential Exclusion Criteria: * Low dose anticoagulation therapy within 2 week prior to study treatment * Anticancer therapy within 2 weeks prior to study treatment * Investigational therapy within 4 weeks of study treatment * Major surgery within 2 weeks of study treatment * Coexisting active infection or other medical condition likely to interfere with trial procedures * Significant cardiovascular disease (NYHA Class III or IV) * Baseline prolongation of QT/QTc * Clinically significant CNS disorder, altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completing trial procedures * Symptomatic or untreated CNS metastases * Pregnant or breast feeding women * Patients not willing to use effective contraception * Known infection with HIV, Hep B or Hep C
References
Publications (0)
Data not yet available
No reference posted for this study.