Clinical trial · Interventional
Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
NCT01280786CI-TRIAL-00013643unknownPhase 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)
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elesclomol Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elesclomol Sodium
- interventionNames
- Drug: Elesclomol Sodium
Primary outcomes (2)
- measure
- Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
- timeFrame
- 1 year
- description
- \- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
- measure
- Measurement of study drug concentrations to characterize pharmacokinetics.
- timeFrame
- 1 year
- description
- \- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy * ECOG performance status of 0-2 * Acceptable organ and marrow function during the screening period as defined by the protocol * Reliable venous access suitable for study drug infusions Exclusion Criteria: * Significant cardiovascular disease * Candidates for hematopoietic stem cell transplant * Women who are pregnant or breast-feeding * Prior treatment with chronic immunosuppressants * Other clinically significant uncontrolled conditions
References
Publications (0)
Data not yet available
No reference posted for this study.