Phase 1
Completed N=29
Phase I Combination Ixabepilone + Cisplatin
Source: ClinicalTrials.gov NCT00832117 ↗Enrolled (actual)
29
Serious AEs
31.0%
Results posted
Mar 2012
Primary outcomePrimary: Participants Experiencing Dose Limiting Toxicity (DLT) — 0; 2 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Experiencing Dose Limiting Toxicity (DLT) |
0; 2 | — |
| PRIMARY Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2 |
60 | — |
| SECONDARY Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 0; 8; 0; 10; 2 | — |
| SECONDARY Percentage of Participants With Response |
— | — |
| SECONDARY Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC) |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria |
4; 1; 7; 2; 4; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria |
19; 5; 6; 3; 18; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00832117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.