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Clinical Trials/NCT00264472
NCT00264472SuspendedPhase 1

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)

Adherex Technologies, Inc.2 sites in 1 country60 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Suspended
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Adherex Technologies, Inc.
Sponsor Class
Industry

Study Sites (2)

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