An Open Label Dose Escalation Study Of E7080

Eisai

Status and phase

Completed

Phase 1

Conditions

Solid Tumor or Lymphoma

Treatments

Drug: Lenvatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00121719

2004-002265-21 (EudraCT Number)

E7080-E044-101

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.

Full description

This is an open-label, non-randomized, dose escalation study. Patients will be treated with lenvatinib 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 greater than grade 1 (except alopecia, lymphopenia and anemia).

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.
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 greater than or equal to 18 years.
Karnofsky performance status greater than or equal 70%.
Written informed consent to participate in the study.

Exclusion criteria

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

Brain tumors or brain or leptomeningeal metastases.
Any of the following laboratory parameters:
1. hemoglobin less than 9 g/dl (5.6 mmol/L)
2. neutrophils less than 1.5 x 10^9/L
3. platelets less than 100 x 10^9/L
4. serum bilirubin greater than 25 micro-mol/l (1.5 mg/dl)
5. other liver parameters greater than 3 x the upper limit of normal (ULN)
6. serum creatinine greater than 1.5 x ULN or creatinine clearance less than 60 ml/minute
Uncontrolled infections.
Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start.
Any treatment with investigational drugs within 30 days before the start of the study.
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.
Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection.
History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
Legal incapacity.
Centrally located or squamous cell carcinoma of the lung.
Proteinuria greater than 1+ on bedside testing.
History of gastrointestinal malabsorption.
Surgery involving gastro- and/or intestinal anastomosis within four weeks of study start.
Patients with bleeding or thrombotic disorders.
Patients using therapeutic dosages of anticoagulants.
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.