Phase 1
Completed N=28
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00832819 ↗Enrolled (actual)
28
Serious AEs
39.3%
Results posted
Mar 2015
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 4 mg BID
Summary
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
4 | — |
| SECONDARY Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel. |
— | — |
| SECONDARY Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel. |
— | — |
| SECONDARY To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel. |
— | — |
Eligibility Criteria
Inclusion criteria
- Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
- Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
- Subjects with Performance Status (PS) 0-1.
- Subjects with adequate organ function.
Exclusion criteria
- Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
- Chemotherapy
- Biological or immunotherapies
- Surgery for primary focus
- The radiation therapy for primary focus
- Subjects with the severe complications or disease history.
- Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
- Subjects with simultaneous or metachronous cancers.
- Subjects who cannot take oral medication.
- Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.
Data sourced from ClinicalTrials.gov (NCT00832819). 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.