A Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459823
Recruitment Status : Suspended
First Posted : April 13, 2007
Last Update Posted : March 24, 2009
Information provided by:
Eisai Inc.

Brief Summary:
Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.

Condition or disease Intervention/treatment Phase
Cancer Drug: E7107 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours
Study Start Date : May 2007
Estimated Primary Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1 Drug: E7107
E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.

Primary Outcome Measures :
  1. To determine MTD of E7107. Safety and tolerability. [ Time Frame: Every six weeks. ]

Secondary Outcome Measures :
  1. Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect. [ Time Frame: Every 21 days. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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

  1. Patients with histologically and/or cytologically confirmed solid tumours who have progressed after receiving approved therapies for their disease and for whom no curative therapies are available.
  2. Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued for at least two weeks previously. All acute toxicities related to these treatments must have resolved.
  3. Aged >= 18 years.
  4. ECOG performance status score of 0 or 1.
  5. Written informed consent prior to any study specific screening procedures, which will include voluntary additional consent to provide specimens specifically for pharmacogenomic analysis, with the understanding that the patient may withdraw consent at any time without prejudice.
  6. Willing and able to comply with the protocol for the duration of the study.
  7. Anticipated life expectancy > three months.
  8. After MTD has been reached: patients must have measurable disease according to RECIST criteria.


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

  1. Symptomatic or progressive brain tumours or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.
  2. Any of the following laboratory parameters:

    1. haemoglobin < 9 g/dL (5.6 mM)
    2. neutrophils <1.5 x 10^9/L
    3. platelets <100 x 10^9/L
    4. serum bilirubin >25 ìM (1.5 mg/dL)
    5. liver function tests (defined as AST and ALT) with values >3 x ULN (5 x ULN if liver metastases are present)
    6. serum creatinine > 105µM (or >1.5 mg/L) or creatinine clearance < 40 mL/min
  3. Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
  4. Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class III according to NYHA classification) including a myocardial infarction within six months of study start.
  5. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants.
  6. History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
  7. Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; peri-menopausal women must have been amenorrheic for at least 12 months, otherwise pregnancy test is required).
  8. Fertile persons who are not willing to use adequate contraception (defined as two forms of contraception including a barrier method).
  9. Patients with a marked screening or baseline prolongation of QT/QTc interval (i.e., repeated demonstration of a QTc interval > 450 msec); a history of additional factors of TdP (i.e., heart failure, hypokalaemia, family history of Long QT Syndrome).
  10. Legal incapacity.
  11. After MTD has been reached: Second malignancy within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00459823

Department of Medical Oncology, Erasmus University Medical Centre
Rotterdam, Netherlands
Medical Oncology Service. Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Eisai Limited
Study Director: Jantien Wanders, M.D. Eisai Limited

Responsible Party: Eisai Limited Medical Information Services, Eisai Limited Identifier: NCT00459823     History of Changes
Other Study ID Numbers: E7107-E044-102
First Posted: April 13, 2007    Key Record Dates
Last Update Posted: March 24, 2009
Last Verified: March 2009

Keywords provided by Eisai Inc.:
solid tumors