Clinical trial · Interventional
Phase I Combination Ixabepilone + Cisplatin
Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors
NCT00832117CI-TRIAL-00047976completedPhase 1Results postedClinicalTrials.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 highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Escalation and Expansion
- interventionNames
- Drug: Ixabepilone
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Participants Experiencing Dose Limiting Toxicity (DLT)
- timeFrame
- Within the first 21 days of first cycle
- description
- DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.
- measure
- Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Escalation Phase Subjects: Primary solid tumor not curable by local measures such as surgery, radiation Inclusion Criteria: * Men and women age ≥ 18 Exclusion: * More than 2 prior chemotherapy containing regimens for metastatic disease * No prior exposure to cisplatin or ixabepilone Expansion Phase Subjects: Advanced Non-small cell lung cancer Inclusion Criteria: * Men and women age ≥ 18 Exclusion: * No prior chemotherapy-containing regimen for metastatic disease * No prior exposure to cisplatin or ixabepilone
References
Publications (0)
Data not yet available
No reference posted for this study.