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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Howard Burris, III, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

Adherex Protocol # AHX-03-104

NCT ID:

NCT00264472

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Neoplasms
  • Cancer
  • Tumors
  • Neoplasms
  • Anticarcinogenic Agents
  • Antineoplastic Agents
  • Dihydrouracil Dehydrogenase (NADP)
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Hepatocellular

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203