Trials / Terminated
TerminatedNCT00165594
A Study of E7070 in Patients With Gastric Cancer
Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (planned)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
Phase I study: To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously administering once every 3 weeks. Phase IIa study: To investigate primary objective (response rate for efficacy assessment) and secondary objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070 in patient with gastric cancer who are EM/IM type by intravenously administering once every 3 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7070 |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2006-07-01
- Completion
- 2006-08-01
- First posted
- 2005-09-14
- Last updated
- 2014-01-23
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00165594. Inclusion in this directory is not an endorsement.