Study of E7389 in Patients With Advanced Solid Tumors

A Phase 1 study testing E7389 in people with Advanced Solid Tumors, run by Eisai Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: E7389
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: Sep 2003to Jul 2005
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
San Antonio, Texas
Study site
The Bronx, New York, 10461

Other trials in United States

About this study

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

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.

Conditions: Advanced Solid Tumors
Being tested: E7389
Keywords: Metastatic Tumors, Advanced Solid Tumors, Stage IV Tumors, Solid Tumors, Recurrent Solid Tumors
Medical subject headings: Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E7389Drug
E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Study groups in NCT00069264
Study group	Role	What they receive
E7389	Experimental	Not described Receives: Drug: E7389

What is being measured

The primary outcome is the main question the study is designed to answer.

Determination of the Maximum Tolerated Dose
Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Jul 2005

First posted24 Sep 2003 (estimated)
Study startSep 2003
Primary completionMar 2005
Study completionJul 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00069264
Sponsor's protocol ID: E7389-A001-101
Other IDs: E7389, BOLD
Status last verified: Nov 2011
First submitted: 19 Sep 2003
Last updated: 20 Dec 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT00069264
Acronym / sponsor ID: E7389-A001-101
Conditions: Advanced Solid Tumors
Keywords: Metastatic Tumors, Advanced Solid Tumors, Stage IV Tumors, Solid Tumors, Recurrent Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Mar 2005 (actual)
Study completion: Jul 2005 (actual)
First posted: 24 Sep 2003 (estimated)
Results: Posted 20 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
E7389	Experimental	Drug: E7389

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E7389E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.	Drug	E7389

Primary outcome

Determination of the Maximum Tolerated Dose
Time frame: 28 Days

Results and safety

Results posted to the registry on 20 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E7389	32	0

Primary outcome: Determination of the Maximum Tolerated Dose

Time frame: 28 Days. Number. Unit: mg/m^2

Measure	E7389 n = 32
Value	1.0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E7389	12 of 32 (37.5%)	32 of 32 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Advanced Solid Tumors

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dale Shuster, Ph.D. study director

Eisai Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7389 in people with Advanced Solid Tumors, run by Eisai Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Maximum Tolerated Dose (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.