CompletedPhase 1NCT00413322

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Checked against the public recordLast updated Jul 8, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations3
SponsorValerio Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Valerio Therapeutics
Interventions being studied
Drug: belinostat; Drug: 5-Fluorouracil (5-FU)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically confirmed solid tumors * Advanced colorectal cancer or other adenocarcinomas * Tumor progression after standard chemotherapy, or where none yet approved * At least one unidimensionally measurable lesion * Karnofsky performance \>= 70% * Life expectancy of at least 3 months * Age \>= 18 years * Signed, written Institutional Review Board (IRB)-approved informed consent * Acceptable liver function: * Bilirubin \<= 1.5 x upper limit of normal (ULN) * AST (SGOT) and ALT (SGPT) \<= 2.5 x ULN, OR * AST (SGOT) and ALT (SGPT) \<= 5 x ULN if liver metastasis * Acceptable renal function: * Serum creatinine within normal limits, OR * Calculated creatinine clearance of \>= 60 mL/min/1.73 m2 for certain patients * Acceptable hematologic status: * Absolute neutrophil count (ANC) \>= 1500 cells/mm3 * Platelet count \>= 100,000 (plt/mm3) * Hemoglobin \>= 9 g/dL * Urinalysis: No clinically significant abnormalities * Acceptable coagulation status: * Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR * For patients on anticoagulation therapy, status within therapeutic range * For men and women of child-producing potential, use of effective contraception * Tumors accessible for needle biopsy Exclusion Criteria: * Significant cardiovascular disease. * A marked baseline prolongation of QT/QTc interval * Long QT syndrome * Required use of medication on dosing days that may cause torsade de pointes. * Infections requiring intravenous (IV) systemic therapy * Pregnant or nursing women * Treatment with chemotherapy or investigational therapy \< 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin). * Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry. * Unwillingness or inability to comply with protocol procedures. * Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C * Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * Concurrent use of other investigational agent(s) * Serious concurrent medical illness

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic ArizonaScottsdale, Arizona
  • University of NebraskaOmaha, Nebraska
  • Portsmouth Regional Hospital Hematology/Oncology ClinicPortsmouth, New Hampshire

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 8, 2015. Always confirm current availability with the study team.

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