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A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable 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: NCT00264472
Recruitment Status : Suspended (Lack of funds)
First Posted : December 13, 2005
Last Update Posted : December 15, 2008
Information provided by:
Adherex Technologies, Inc.

Brief Summary:
5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in subjects with refractory solid tumors.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: ADH300004 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Part Phase 1 Study Evaluating the Safety and Anti-Tumor Activity of ADH300004 (Eniluracil) Administered With 5-Fluorouracil (5-FU), and the Pharmacokinetics of 5-FU Given as: 5.0 mg ADH300004 With Escalating Doses of 5-FU Administered Orally 3 Weeks Out of 4 in Subjects With Refractory Solid Tumors (Part 1); or 5.0 mg ADH300004 With 5 FU Administered Orally as a Split Dose for 3 Weeks Out of 4 in Subjects With Hepatocellular Carcinoma, Non-Small Cell Lung Carcinoma, Gastric Cancer, Cervical Cancer, Prostate Cancer, or Breast Cancer (Part 2) (Adherex Protocol Number AHX-03-104)
Study Start Date : January 2006
Estimated Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: ADH300004
    5 mg

Primary Outcome Measures :
  1. Part 1: To determine the DLTs and MTD of the combination of ADH300004 and 5 FU administered orally in a weekly regimen, for 3 weeks with 1 week rest per cycle, in subjects with incurable solid tumors [ Time Frame: 4 weeks ]
  2. Part 2: To determine the DLTs and MTD of the combination of ADH300004 and 5-FU administered orally as a split dose for 3 out of 4 weeks in subjects with HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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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:

  • Signed written informed consent
  • > or = 18 years of age
  • Advanced or metastatic solid tumors:

Part 1: Histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists

Part 2: Histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

  • Radiologically documented measurable or evaluable (non-measurable) disease
  • Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
  • Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study

Exclusion Criteria:

  • Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
  • Non-cytotoxic cancer therapy within 14 days prior to study entry
  • Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
  • Ascites that is refractory to conservative management
  • Inability to take oral medication
  • Active peptic ulcer disease
  • Known hypersensitivity to 5-FU or ADH300004
  • Stroke, major surgery, or other major tissue injury within 30 days before study entry

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): NCT00264472

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United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Adherex Technologies, Inc.
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Principal Investigator: Howard Burris, III, MD SCRI Development Innovations, LLC

Additional Information:
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Responsible Party: Clinical Study Manager, Adherex Technoloogies Identifier: NCT00264472     History of Changes
Other Study ID Numbers: Adherex Protocol # AHX-03-104
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008
Keywords provided by Adherex Technologies, Inc.:
Anticarcinogenic Agents
Antineoplastic Agents
Dihydrouracil Dehydrogenase (NADP)
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
Enzyme Inhibitors