Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

E7080

Akihiko Tsuruoka

The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.

An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.

DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.

Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

Eisai Inc.

All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses. Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

E7080 Group

Age, Continuous

Male

Female

Sex/Gender, Customized

To Elucidate the Pharmacokinetic Profile of E7080

Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.

Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day

All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.

Spots Global Cancer Trial Database for An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial