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A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma

Phase 1
18 Years
Not Enrolling
Metastatic Melanoma

Thank you

Trial Information

A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma

Inclusion Criteria:

Patients with a histologically and/or cytologically confirmed solid tumor or lymphoma who
are resistant/refractory to approved therapies or for whom no curative therapies are
available All previous treatment (including surgery and radiotherapy) must have been
completed at least four weeks prior to study entry and any acute toxicities must have
resolved Aged 18 years. Because of the potential additional risk to children suggested
by preclinical models of dysplasia in growing epiphyseal growth plates, enrollment will be
limited to adult patients ECOG performance status score of 0 or 1 Written informed consent
prior to any study specific screening procedures with the understanding that the patient
may withdraw consent at any time without prejudice Willing and able to comply with the
protocol guidelines for the duration of the study For patients in the Schedule 2 Expanded
Melanoma Cohort only: histologically and/or cytologically confirmed advanced and/or
metastatic melanoma who are resistant/refractory to approved therapies or for whom no
curative therapies are available. In addition, patients must have melanoma lesions
amenable to tissue biopsy and must agree to undergo biopsies of malignant and adjacent
non-malignant tissue pretreatment and at the end of Cycle 1 of treatment For patients in
the Melanoma Combination Cohort only: histologically and/or cytologically confirmed
melanoma that is advanced and/or metastatic

Exclusion Criteria:

Untreated or unstable metastases to the central nervous system (CNS) tumors. Patients who
have completed local therapy and have discontinued the use of steroids for this indication
at least 4 weeks prior to commencing treatment and in whom stability has been proven by at
least 2 CT or MRI scans obtained at least 4 weeks apart are permitted Any of the following
laboratory parameters: hemoglobin < 9 g/dL (5.6 mmol/L); neutrophils <1.5 x 109/L;
platelets <100 x 109/L; serum bilirubin >25 mol/L (1.5 mg/dL); liver function tests with
values >3 x upper limit of normal (ULN); renal function with serum creatinine >1.5 ULN or
creatinine clearance < 60 mL/min Positive history of HIV, active hepatitis B or active
hepatitis C or severe/uncontrolled intercurrent illness or infection Patients with
centrally located non-small cell lung cancers and squamous cell lung cancers Clinically
significant cardiac impairment or unstable ischemic heart disease including a myocardial
infarction within six months of study start Patients with marked Baseline prolongation of
QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the
Fridericia method for QTc analysis Bleeding or thrombotic disorders, or using therapeutic
dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet
agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered
exclusionary if taken <7 days per 28 days. However, if the patient requires chronic use
(>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is
excluded. Concomitant antiplatelet agents and NSAIDs should be used with caution
Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs
(NSAIDs) Poorly controlled hypertension (defined as requiring changes in any hypertensive
regimen within 1 weekthree months of study entry) or patients diagnosed with hypertension
based on repeat blood pressure measurements of >160/90 mmHg at Screening >1+ proteinuria
on urine dipstick testing or 30 mg/dL A history of gastrointestinal malabsorption or
having undergone surgery requiring gastrointestinal anastomoses within four weeks of
starting therapy or who have not recovered from major surgery within three weeks of
starting therapy History of alcoholism, drug addiction, or any psychiatric or
psychological condition which, in the opinion of the Investigator, would impair study
compliance Any treatment with investigational drugs within 30 days before the start of the
study Previous treatment with E7080 Known intolerance to temozolomide (or any of the
excipients) Women who are pregnant or breast-feeding; women of childbearing potential with
a positive pregnancy test at Screening or no pregnancy test. Women of childbearing
potential unless (1) surgically sterile or (2) using adequate measures of contraception
(including two forms of contraception, one of which must be a barrier method) in the
opinion of the Investigator (revised per Amendment 04). Perimenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential Fertile
males with female partners who are not willing to use contraception or whose female
partners are not using adequate contraceptive protection Legal incapacity

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions.

Outcome Time Frame:

Every two cycles.

Safety Issue:


Principal Investigator

Eisai Inc.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Metastatic Melanoma
  • cancer
  • Melanoma



Austin, Texas  78705