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An Open Label Phase I Dose Escalation Study Of E7080


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor or Lymphoma

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Trial Information

An Open Label Phase I Dose Escalation Study Of E7080


This is an open-label, non-randomized, dose escalation study. Patients will be treated with
E7080 once daily. Each four-week treatment period will be considered to be one treatment
cycle. The selection of subsequent dose levels will be performed according to an accelerated
design: Although initially 3 patients per dose level will be entered, the next dose level
can be opened for patient accrual after only the first patient in the previous cohort
completes Cycle 1 with no drug-related toxicity >grade 1 (except alopecia, lymphopenia and
anemia).

Inclusion Criteria


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 tumor or lymphoma
who are resistant/refractory to approved therapies or for whom no appropriate
therapies are available.

2. 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.

3. Aged >= 18 years.

4. Karnofsky performance status >= 70%.

5. Written informed consent to participate in the study.

EXCLUSION CRITERIA:

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

1. Brain tumors or brain or leptomeningeal metastases.

2. Any of the following laboratory parameters:

1. hemoglobin < 9 g/dl (5.6 mmol/L)

2. neutrophils <1.5 x 10^9/L

3. platelets <100 x 10^9/L

4. serum bilirubin >25 ┬Ámol/l (1.5 mg/dl)

5. other liver parameters >3 x the upper limit of normal (ULN)

6. serum creatinine >1.5 x ULN or creatinine clearance < 60 ml/minute

3. Uncontrolled infections.

4. Clinically significant cardiac impairment or unstable ischemic heart disease
including a myocardial infarction within six months of study start.

5. Any treatment with investigational drugs within 30 days before the start of the
study.

6. Pregnancy or lactation (all women of childbearing potential must have a negative
pregnancy test before inclusion in the study; post-menopausal women must be
amenorrheic for at least 12 months). Female patients of childbearing potential must
use adequate contraceptive protection, defined as two forms of contraception, one of
which must be a barrier method.

7. Fertile males not willing to use contraception or whose female partners are not using
adequate contraceptive protection.

8. History of alcoholism, drug addiction, or any psychiatric or psychological condition
which, in the opinion of the investigator, would impair study compliance.

9. Legal incapacity.

10. Centrally located or squamous cell carcinoma of the lung.

11. Proteinuria > 1+ on bedside testing.

12. History of gastrointestinal malabsorption.

13. Surgery involving gastro- and/or intestinal anastomosis within four weeks of study
start.

14. Patients with bleeding or thrombotic disorders.

15. Patients using therapeutic dosages of anticoagulants.

16. Poorly controlled hypertension (defined as a change in hypertensive therapy within
three months of study start) or patients diagnosed with hypertension (defined as a
repeat blood pressure measurement of 160/90 mmHg or higher) at screening.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The maximum tolerated dose as defined by an incidence of dose limiting toxicity of no more than 17% (one in six).

Outcome Time Frame:

First four weeks of treatment.

Safety Issue:

Yes

Principal Investigator

Jantien Wanders, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

E7080-E044-101

NCT ID:

NCT00121719

Start Date:

July 2005

Completion Date:

June 2009

Related Keywords:

  • Solid Tumor or Lymphoma
  • Resistant and refractory solid tumors
  • lymphomas
  • hodgkins disease
  • non-hodgkins lymphoma
  • neoplasms
  • Lymphoma

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