Study of E7389 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069264
• Other study ID #: E7389-A001-101
• Secondary ID: E7389BOLD
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2003
• Last updated: November 16, 2011
• Start date: September 2003
• Est. completion date: July 2005

Study information

• Verified date: November 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients must have a histologically or cytologically confirmed and measurable advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy)

• Patients may have received prior chemotherapy

• Patients must be aged > 18 years

• Patients must have a Karnofsky Performance Status of > 70%

• Patients must have a life expectancy of > 3 months

• Patients must have adequate renal function as evidenced by serum creatinine <1.5mg/dL or creatinine clearance >= 45mL/minute

• Patients must have adequate bone marrow function as evidenced by absolute neutrophil count > 1,500/µL and platelets > 100,000/µL

• Patients must have adequate liver function as evidenced by bilirubin < 1.5mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2 times the upper limits of normal (ULN)unless related to liver involvement by tumor, in which case <= 5.0 times ULN

• Patients must be willing and able to comply with the study protocol for the duration of the study

• Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice

Exclusion Criteria

• Patients who have received chemotherapy within three weeks (six weeks if nitrosoureas were received) of E7389 treatment start

• Patients who have not recovered from any chemotherapy related or other therapy related toxicity at study entry

• Patients who require active anti-coagulant therapy

• Women who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)

• Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception

• Patients who have not successfully completed local therapy for previously treated central nervous system (CNS) metastases and who have not been discontinued from corticosteroids for at least four weeks before starting treatment with E7389. Patients with asymptomatic brain metastases who have no evidence of midline shift on CT scan or MRI may be enrolled without initiation of local therapy for the CNS metastases. In this case, a repeat scan must be performed within four weeks of the original scan to ensure that disease progression is not occurring.

• Patients who have tested positive for HIV

• Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies)

• Patients with uncontrolled cardiovascular illness defined as unstable angina, myocardial infarction within 6 months prior to study entry, symptomatic congestive heart failure (CHF) (NYHA II or higher) clinical evidence of CHF, or clinical evidence of serious cardiac arrhythmia

• Patients with organ allografts

• Patients who have received investigational drugs, including immunotherapy, gene therapy, hormone therapy, or other biologic therapy; anti-neoplastic therapy; or radiation therapy (other than required for palliation) within three weeks of E7389 treatment start

• Patients who have had major surgery within four weeks of E7389 treatment start without a full recovery

• Patients with a hypersensitivity to Halichondrin B and/or Halichondrin B-like compounds

• Patients with other significant disease that, in the Investigator's opinion, would exclude the patient from the study

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• E7389
E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the Maximum Tolerated Dose		28 Days	Yes

External Links

•   Link