An Open Label Dose Escalation Study Of E7080

NCT ID: NCT00121719

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-01
• Study Completion Date: 2019-03-01

Brief Summary

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

Detailed 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).

Conditions

Solid Tumor or Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Lenvatinib tablets taken orally, once daily.

Interventions

Lenvatinib

Lenvatinib tablets taken orally, once daily.

Intervention Type: DRUG

Other Intervention Names

E7080

Eligibility Criteria

Inclusion Criteria

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 greater than or equal to 18 years.

4. Karnofsky performance status greater than or equal 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 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

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 greater than 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Netherlands Cancer Institute- Antoni Van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Gartnavel General Hospital

Glasgow, , United Kingdom

Countries

Netherlands; United Kingdom

Other Identifiers

2004-002265-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7080-E044-101

Identifier Type: -

Identifier Source: org_study_id