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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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

Inclusion Criteria


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

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


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.

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 MTD of E7107. Safety and tolerability.

Outcome Time Frame:

Every six weeks.

Safety Issue:


Principal Investigator

Jantien Wanders, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited


Spain: Spanish Agency of Medicines and Health Products (AEMPS)

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • solid tumors