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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00413322
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Onxeo

Tracking Information
First Submitted Date  ICMJE December 18, 2006
First Posted Date  ICMJE December 19, 2006
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE September 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU [ Time Frame: throughout the study ]
  • to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors [ Time Frame: throughout the study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tumor
Intervention  ICMJE
  • Drug: belinostat
    300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
    Other Name: PXD101
  • Drug: 5-Fluorouracil (5-FU)
    250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.
    Other Name: 5-FU
Study Arms  ICMJE Experimental: Single-arm dose escalation
Interventions:
  • Drug: belinostat
  • Drug: 5-Fluorouracil (5-FU)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
35
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00413322
Other Study ID Numbers  ICMJE PXD101-CLN-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Onxeo
Study Sponsor  ICMJE Onxeo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Topotarget A/S Onxeo
PRS Account Onxeo
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP