Clinical trial · Interventional
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients
A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
NCT00289809CI-TRIAL-00002907completedPhase 1 / Phase 2ClinicalTrials.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 purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response
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 |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination of TLC D-99 and Ifosfamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
- timeFrame
- Definition of TDL
- measure
- Phase II: Response rate (CR/PR or SD)
- timeFrame
- Tumor assessment
Secondary outcomes (1)
- measure
- Phase II: time to progression, duration of response, overall survival
- timeFrame
- Tumor assessment, follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy * Age \>/=18 yrs * PS \</=2 * Disease detectable almost for 1 dimension * Life expectancy \>/=3 mos * Minimum 4 wks from last radiotherapy * Adequate medullary, liver, and renal functions * Normal LVEF * Written Informed Consent Exclusion Criteria: * Pregnant or breast-feeding patients * Serious concomitant disease or not controlled infections
References
Publications (0)
Data not yet available
No reference posted for this study.