An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
|ClinicalTrials.gov Identifier: NCT00280397|
Recruitment Status : Completed
First Posted : January 23, 2006
Results First Posted : March 6, 2015
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer: Solid Tumors||Drug: E7080||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||November 2008|
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.
- Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day [ Time Frame: up to 4 weeks ]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.
- DLT of E7080 Repeatedly Administered Twice a Day [ Time Frame: up to 4 weeks ]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.
- To Elucidate the Pharmacokinetic Profile of E7080 [ Time Frame: Every 3 weeks ]
- Number of Participants With Adverse Events / Serious Adverse Events [ Time Frame: Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons. ]Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
- Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile [ Time Frame: Every 3 weeks ]
- Evaluate the Anti-tumor Activity of E7080 [ Time Frame: Every 3 weeks ]
- To Make Exploratory Analyses of Pharmacodynamic Markers [ Time Frame: Every 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280397
|Tokyo, Japan, 104-0045|
|Study Director:||Akihiko Tsuruoka||Eisai Co., Ltd.|