Clinical trial · Interventional
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors
NCT00827203CI-TRIAL-00002117suspendedPhase 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)
The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.
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 |
|---|---|---|---|
| Metastatic Solid Tumors | Solid Neoplasm | 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
- Cohort
- interventionNames
- Drug: Elesclomol Sodium
Primary outcomes (2)
- measure
- To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
- timeFrame
- Jan 2011
- measure
- To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion
- timeFrame
- Jan 2011
Secondary outcomes (3)
- measure
- To inform dose selection for future study using a once-a-week schedule
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Males and females at least 18 years of age * Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable * Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy * Acceptable organ and marrow function during the Screening Period as defined by the protocol. * Reliable venous access suitable for weekly study drug infusions * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria * Pregnant or breast-feeding women * Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study * Primary brain tumors or active brain metastases * Treatment with chronic immunosuppressants * Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
References
Publications (0)
Data not yet available
No reference posted for this study.