An Open Label Dose Escalation Study Of E7080

NCT00121719 | Completed Phase 1 Results

• 2 other identifiers: E7080-E044-1012004-002265-21
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Solid Tumor or Lymphoma

Keywords

Resistant and refractory solid tumors; lymphomas; hodgkins disease; non-hodgkins lymphoma; neoplasms

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.

  Cycle 1 (4 weeks)

Secondary Outcomes (16)

• Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  First date of study treatment to date of last dose of study treatment, up to approximately 13 years and 8 months

• Dose-limiting Toxicities (DLTs)

  Cycle 1 (4 weeks) of each dose level

• Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%

  First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 13 years and 8 months

• Best Overall Response (BOR)

  Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years

• Maximum Plasma Concentration (Cmax) of Lenvatinib

  Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)

Other Outcomes (1)

• Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples

  Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment

Study Arms (1)

1

EXPERIMENTAL

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

Lenvatinib tablets taken orally, once daily.

Also known as: E7080

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• hemoglobin less than 9 g/dl (5.6 mmol/L)
• neutrophils less than 1.5 x 10\^9/L
• platelets less than 100 x 10\^9/L
• serum bilirubin greater than 25 micro-mol/l (1.5 mg/dl)
• other liver parameters greater than 3 x the upper limit of normal (ULN)
• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Netherlands Cancer Institute- Antoni Van Leeuwenhoek Hospital

Amsterdam, 1066 Cx, Netherlands

Location

Gartnavel General Hospital

Glasgow, G12 0Yn, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

+1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Primary Completion: June 19, 2009
• Study Completion: March 1, 2019
• Last Updated: June 22, 2023
• Results First Posted: May 27, 2016

Record last verified: 2020-03

Locations

GB (1); NL (1)