Clinical trial · Interventional
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003
A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003
NCT00405873CI-TRIAL-00009777terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 efficacy
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma The primary endpoint is best overall response rate within 20 weeks after registration
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 |
|---|---|---|---|
| AMT2003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMT2003
- interventionNames
- Drug: AMT2003
Primary outcomes (1)
- measure
- Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
- timeFrame
- March 2010
Secondary outcomes (4)
- measure
- Progression Free Survival (PFS) time
- timeFrame
- March 2010
- measure
- Overall Survival (OS) time
- timeFrame
- March 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer confirmed by histology or cytology * At least one measurable lesion * Advanced disease refractory to standard therapy or for which no standard therapy exists * Life expectancy of at least 3 months Exclusion Criteria: * Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma * Body weight below 45 kg * Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control * Confirmed diagnosis of HIV * Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II * Chemotherapy or radiotherapy less than 4 weeks prior to entry * Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) * Participation in a clinical trial less than 30 days prior to entry into study
References
Publications (0)
Data not yet available
No reference posted for this study.