NCT00280397

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2015

Completed
Last Updated

October 7, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

January 20, 2006

Results QC Date

February 21, 2015

Last Update Submit

August 29, 2016

Conditions

Cancer: Solid Tumors

Keywords

Cancer, solid tumors

Outcome Measures

Primary Outcomes (2)

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

    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.

    up to 4 weeks

  • DLT of E7080 Repeatedly Administered Twice a Day

    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.

    up to 4 weeks

Secondary Outcomes (5)

  • To Elucidate the Pharmacokinetic Profile of E7080

    Every 3 weeks

  • Number of Participants With Adverse Events / Serious Adverse Events

    Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.

  • Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile

    Every 3 weeks

  • Evaluate the Anti-tumor Activity of E7080

    Every 3 weeks

  • To Make Exploratory Analyses of Pharmacodynamic Markers

    Every 3 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: E7080

Interventions

E7080DRUG

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.

1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have histologically and/or cytologically confirmed solid tumors requiring treatment.
  • Patients with solid tumors which are resistant to approved conventional anti-tumor therapies, or for which no appropriate treatment is available.
  • Patients who had completed all previous treatments (including surgery and radiotherapy) and supportive care (such as transfusion of blood, blood components and granulocyte colony-stimulating factor \[G-CSF\] treatment) at least 4 weeks before registration, and no sign or symptom of acute toxicity occurred in previous treatments.
  • Patients 20 years or older and less than 75 years of age at the time of registration.
  • Patients with 0 or 1 Performance Status (PS) established by Eastern Cooperative Oncology Group (ECOG.)
  • Patients who can stay in hospital for more than 1 cycle of treatment.
  • Patients who are expected to survive for more than 3 months from the start of study drug administration.
  • Patients who have provided written informed consent for the participation in the study.

You may not qualify if:

  • Patients with clinical symptoms due to brain metastases requiring treatment.
  • Patients who have any of the following laboratory test findings:
  • Hemoglobin less than 9.0 g/dL
  • Neutrophil count less than 1.5 x 10 9/L
  • Platelet count less than 100 x 10 9/L
  • Serum bilirubin greater than 1.5 mg/dL
  • AST, ALT greater than 100 IU/L
  • Serum creatinine greater than 1.5 mg/dL or creatinine clearance less than 50 mL/minute
  • Patients with positive reaction for human immunodeficiency virus (HIV) or hepatitis virus C (HCV) antibody or hepatitis B virus surface (HBs) antigen, or patients with untreated serious infections.
  • Patients with clinically significant cardiac disorders or unstable ischemic heart diseases including myocardial infarction within six months before the registration for the study.
  • Patients with marked Baseline prolongation of QT/QTc interval (QTc interval greater than 450 msec for males or greater than 470 msec for females) using the Fridericia method for QTc analysis.
  • Patients with hemorrhagic or thrombotic diseases or who are using therapeutic doses of anticoagulants such as aspirin, warfarin, or ticlopidine.
  • Patients who are diagnosed with hypertension (defined as repeatedly measured blood pressure = 160/90 mmHg) at Screening, irrespective of use of antihypertensive drugs.
  • Patients who have proteinuria greater than 1 on bedside testing.
  • Patients who have history of insufficient gastrointestinal absorption, or patients who received gastric or intestinal anastomoses within 4 weeks before registration.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Tokyo, 104-0045, Japan

Location

Related Publications (2)

  • Koyama N, Saito K, Nishioka Y, Yusa W, Yamamoto N, Yamada Y, Nokihara H, Koizumi F, Nishio K, Tamura T. Pharmacodynamic change in plasma angiogenic proteins: a dose-escalation phase 1 study of the multi-kinase inhibitor lenvatinib. BMC Cancer. 2014 Jul 21;14:530. doi: 10.1186/1471-2407-14-530.

    PMID: 25047123DERIVED

  • Yamada K, Yamamoto N, Yamada Y, Nokihara H, Fujiwara Y, Hirata T, Koizumi F, Nishio K, Koyama N, Tamura T. Phase I dose-escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2528-37. doi: 10.1158/1078-0432.CCR-10-2638. Epub 2011 Mar 3.

    PMID: 21372218DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

lenvatinib

Results Point of Contact

Title
Akihiko Tsuruoka
Organization
Eisai Co., Ltd.
+81-3-3817-5252

Study Officials

  • Akihiko Tsuruoka

    Eisai Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

October 7, 2016

Results First Posted

March 6, 2015

Record last verified: 2016-08

Locations

JP(1)