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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)

Trial Profile

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)

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 25 Nov 2013

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At a glance

  • Drugs Eniluracil (Primary) ; Fluorouracil (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions
  • Sponsors Fennec Pharmaceuticals
  • Most Recent Events

    • 14 Dec 2008 Status changed from recruiting to suspended.
    • 15 Aug 2008 Planned patient number changed from 28 to 60, a reported by ClinicalTrials.gov.
    • 05 Aug 2008 The expected completion date for this trial is now 1 Jun 2009, according to ClinicalTrials.gov.
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