Clinical trial · Interventional
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
NCT00327223CI-TRIAL-00001345completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imexon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imexon
- description
- Dose escalation of imexon
- interventionNames
- Drug: imexon
Primary outcomes (3)
- measure
- Determine the maximally tolerated dose
- measure
- determine the pharmacokinetics
- measure
- determine the toxicity of the drug on the designated schedule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously treated malignant disease of any type. * Prior treatment; at least one prior regimen required. * Able to perform the activities of daily living. * Off prior cancer therapy for at least 4 weeks. * If female, neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No other current drug therapy for the cancer. * Blood counts and blood chemistries in or near normal range. * Prior radiation is permitted. Exclusion Criteria: * No active brain metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.