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A Dose Escalation Study of E7080 Administered to Patients With Solid Tumors or Lymphomas
This study is currently recruiting participants.
Verified by Eisai Inc., August 2009
First Received: July 15, 2005   Last Updated: September 1, 2009   History of Changes
Sponsor: Eisai Inc.
Information provided by: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00121680
  Purpose

The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.

Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.


Condition Intervention Phase
Lymphoma
Neoplasms
Solid Tumors
Drug: E7080
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors or Lymphomas

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions. [ Time Frame: Every two cycles. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify the dose limiting toxicities (DLT); explore safety and tolerability; determine pharmacokinetic profile; explore anti-tumor efficacy. [ Time Frame: Every two cycles. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: E7080
Oral.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.

Inclusion Criteria:

Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.

  • 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
  • Age >= 18 years
  • 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

Exclusion Criteria:

Patients with the following characteristics will not be eligible for the study:

  • Brain tumors or brain or leptomeningeal (CNS) metastases
  • Any of the following laboratory parameters:

    • hemoglobin < 9 g/dL (5.6 mmol/L);
    • neutrophils <1.5 x 10^9/L;
    • platelets <100 x 10^9/L;
    • serum bilirubin >25 µmol/L (1.5 mg/dL);
    • liver function tests with values >3 x ULN;
    • serum creatinine >1.5 x ULN or creatinine clearance < 60 mL/minute
  • Positive history of HIV, active hepatitis B or active hepatitis C, or severe/uncontrolled intercurrent illness or infection
  • 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
  • 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 three months of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening
  • Proteinuria > 1+ on urine dipstick testing
  • 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
  • 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 in the opinion of the Investigator. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121680

Contacts
Contact: Eisai Medical Services 1-888-422-4743

Locations
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Barbara Koetz, MRCP, MSc Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Limited ( Barbara Koetz, MRCP, MSc )
Study ID Numbers: E7080-A001-102
Study First Received: July 15, 2005
Last Updated: September 1, 2009
ClinicalTrials.gov Identifier: NCT00121680     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010