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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. Identifier: NCT00413322
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Tumor Drug: belinostat Drug: 5-Fluorouracil (5-FU) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: Single-arm dose escalation 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

Primary Outcome Measures :
  1. to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU [ Time Frame: throughout the study ]
  2. to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors [ Time Frame: throughout the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413322

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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198-7680
United States, New Hampshire
Portsmouth Regional Hospital Hematology/Oncology Clinic
Portsmouth, New Hampshire, United States, 03801
Sponsors and Collaborators
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Study Chair: Topotarget A/S Onxeo
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Responsible Party: Onxeo Identifier: NCT00413322    
Other Study ID Numbers: PXD101-CLN-4
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by Onxeo:
mesothelioma, cystic
Advanced Solid tumor
Androgen-independent prostate cancer
bladder cancer
bladder neoplasms
Breast cancer
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Coin Lesion, Pulmonary
colorectal cancer
Esophageal Neoplasms
Facial Neoplasms
head and neck cancer
Histiocytoma, Malignant Fibrous
kidney cancer
lung cancer
lung neoplasms
Mixed Tumor, Mesodermal
Mouth Neoplasms
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Histone Deacetylase Inhibitors
Enzyme Inhibitors