Phase 3
Completed N=300
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00660504 ↗Enrolled (actual)
300
Serious AEs
9.7%
Results posted
Jul 2014
Primary outcomePrimary: Overall Survival — 11.79; 10.28 month
Summary
This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
11.79; 10.28 | — |
| SECONDARY Progression-Free Survival |
6.83; 5.72 | — |
| SECONDARY Objective Response Rate |
69.80; 57.33 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically/cytologically proven small cell lung cancer
- Extensive disease
- No prior chemotherapy regimen
- Age 18 years or older
- ECOG performance status of 0-1
Exclusion Criteria
- Brain metastasis requiring treatment
- Treatment (Surgical or radiotherapy)of primary tumor
- Interstitial pneumonia or pulmonary fibrosis
- Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
Data sourced from ClinicalTrials.gov (NCT00660504). 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.