A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264472

Enrollment

Registered

2005-12-13

Start date

2006-01-31

Completion date

Unknown

Last updated

2008-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer, Tumors, Neoplasms, Anticarcinogenic Agents, Antineoplastic Agents, Dihydrouracil Dehydrogenase (NADP)

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.

Interventions

DRUGADH300004

5 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	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	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026