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
Study Sites (2)
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