Clinical trial · Interventional
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
NCT00420485CI-TRIAL-00010093completedPhase 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 study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gimatecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Daily times five schedule
- interventionNames
- Drug: gimatecan
- type
- EXPERIMENTAL
- label
- Continuous schedule, twice daily
- interventionNames
- Drug: gimatecan
Primary outcomes (1)
- measure
- Presence of dose limiting toxicities in a 56-day treatment period
- timeFrame
- 56 days
Secondary outcomes (5)
- measure
- safety and tolerability assessed by adverse events, serious adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Advanced or metastatic cancer * 18 years and above Exclusion criteria: * Previous treatment with 4 or more cycles of carboplatin; * Previous treatment with 2 or more courses of nitrosourea or mitomycin; * Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve; * Severe and/or uncontrolled medical conditions Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.