Clinical trial · Interventional
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
NCT00332280CI-TRIAL-00009775terminatedPhase 2 / Phase 3ClinicalTrials.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. Stopped at first interim evaluation point
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 disease. The primary evaluation criterion is clinical benefit response.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Genital Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
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
- Improvement in clinical benefit response
- timeFrame
- Jan 2010
Secondary outcomes (6)
- measure
- Progression free survival
- timeFrame
- Jan 2010
- measure
- Overall survival
- timeFrame
- Jan 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 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 birth control methods * Concurrent severe or uncontrolled medical disease * Acute or chronic liver disease * 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 this study
References
Publications (0)
Data not yet available
No reference posted for this study.