Clinical trial · Interventional
A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
A Phase 1/2 Study in Subjects With Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma, Evaluating the Safety, and Anti-Tumor Activity of ADH300004 (Eniluracil) With Escalating Doses of 5 Fluorouracil Administered Orally Once Weekly for 3 Weeks Out of Every 4 (Adherex Protocol Number AHX-03-103)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funds
Summary
Brief summary (as posted)
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 locally advanced, recurrent, or metastatic hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADH300004 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * In the Phase I portion, Asian subjects that are \> or = to 18 years of age * In the Phase II portion, any subjects that are \> or = to 18 years of age * Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein \[AFP\] \> 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein \[AFP\] \> 400 ng/mL, hepatitis B surface antigen negative) * Radiologically documented 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: * Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry * No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy) * 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 * History of primary brain tumors or brain metastases * Previous or concurrent malignancy at another site within the last 5 years * Stroke, major surgery, or other major tissue injury within 30 days before study entry
References
Publications (0)
Data not yet available