- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069277
Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors
April 6, 2012 updated by: Eisai Inc.
A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) Administered Once Every Three Weeks in Patients With Advanced Solid Tumors
The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo.
The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90025
- Cancer Institute Medical Group
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Santa Monica, California, United States, 90404
- Premiere Oncology
-
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New Jersey
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New Brunswick, New Jersey, United States, 08901
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 (limit of two prior chemotherapy regimens)
- 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 <1.5 mg/dL or creatinine clearance > 60 mL/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 < 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) < 2 times the upper limits of normal
- 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 therapeutic doses of anti-coagulant therapy (eg, Coumadin, heparin, low molecular weight heparin). Low doses of anticoagulants used for patency (e.g., lines, catheters, ports) are permitted.
- 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 cardiovascular impairment
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.
Time Frame: 12 Weeks
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dale Schuster, Ph.D, Eisai Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 19, 2003
First Submitted That Met QC Criteria
September 23, 2003
First Posted (Estimate)
September 24, 2003
Study Record Updates
Last Update Posted (Estimate)
April 11, 2012
Last Update Submitted That Met QC Criteria
April 6, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E7389-A001-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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