Study of E7389 in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00069264
First received: September 19, 2003
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: E7389
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Determination of the Maximum Tolerated Dose [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: September 2003
Study Completion Date: July 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E7389 Drug: E7389
E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069264

Locations
United States, New York
Bronx, New York, United States, 10461
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Dale Shuster, Ph.D. Eisai Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00069264     History of Changes
Other Study ID Numbers: E7389-A001-101, E7389, BOLD
Study First Received: September 19, 2003
Results First Received: November 16, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Metastatic Tumors
Advanced Solid Tumors
Stage IV Tumors
Solid Tumors
Recurrent Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014