NCT00047034

Brief Summary

Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

5.2 years

First QC Date

October 3, 2002

Last Update Submit

January 4, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0

    Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by cycle.

    28 days

Secondary Outcomes (2)

  • Pharmacokinetics of eribulin mesylate

    At baseline and at the first and third dose of treatment

  • In vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry

    At pre- and post-treatment

Study Arms (1)

Treatment (eribulin mesylate)

EXPERIMENTAL

Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: eribulin mesylateOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

eribulin mesylateDRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog
Treatment (eribulin mesylate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (eribulin mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (eribulin mesylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced, histologically-confirmed solid tumors refractory to standard therapy or for which no standard therapy exists
  • Karnofsky performance status of at least 60% and estimated survival of at least two months
  • Serum creatinine =\< 1.5 mg/dl or creatinine clearance \>= 60 ml/min
  • ANC \>= 1,500/ul
  • Platelets \>= 100,000/ul
  • Bilirubin =\< 1.5 mg/dl
  • SGOT and SGPT =\< 2.5 times the upper limits of normal
  • Prior to entry on study, a patient must be at least four weeks from prior chemotherapy (six weeks from nitrosoureas, 8 weeks from UCN-01) and have recovered from all side effects of prior therapy; there is no limit on the number of prior chemotherapy regimens
  • Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
  • Patients with brain metastases are INELIGIBLE for this study
  • Due to concerns regarding possible drug interactions, patients with HIV taking anti-retroviral medications are INELIGIBLE
  • Pregnant patients and patients who are breast feeding are INELIGIBLE; all patients of child-bearing potential, both male and female, must be advised to practice adequate contraception; premenopausal women must have a negative pregnancy test prior to entry on this study
  • Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it inappropriate to treat the patient on this protocol are INELIGIBLE
  • Patients currently being treated for a severe infection or who are recovering from major surgery are INELIGIBLE until recovery is deemed complete by the investigators
  • All patients must have evaluable disease; the presence of measurable disease is NOT required for this phase I study; if unidimensionally measurable disease is present, baseline measurements of up to 3 indicator lesions should be made no earlier than four weeks prior to the first cycle of chemotherapy; pleural effusions, ascites and bone metastases are not considered measurable
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

eribulin

Study Officials

  • Robert Morgan

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

October 1, 2007

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

US(1)