CancerPhase 1NCT00069277
Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors
A Phase 1 study testing E7389 in people with Cancer, run by Eisai Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- E7389
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2003to Apr 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 (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
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- 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.
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 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cancer Institute Medical Group
Los Angeles, California, 90025
Study site
New Brunswick, New Jersey, 08901
Premiere Oncology
Santa Monica, California, 90404
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- E7389
- Keywords
- Cancer, tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7389Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2003 (estimated)
- Study startAug 2003
- Primary completionApr 2005
- Study completionApr 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 CancerStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dale Schuster, Ph.D, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069277
- Sponsor's protocol ID
- E7389-A001-102
- Status last verified
- Apr 2012
- First submitted
- 19 Sep 2003
- Last updated
- 11 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. 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) Administered Once Every Three Weeks in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00069277
- Acronym / sponsor ID
- E7389-A001-102
- Conditions
- Cancer
- Keywords
- Cancer, tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 24 Sep 2003 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (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
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 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)
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 |
|---|---|---|
| E7389 | Drug | – |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Schuster, Ph.D study director
Eisai Inc.
3 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 Cancer, run by Eisai Inc. at 3 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 9 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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 9 Feb 2012). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2012; AzTrials last refreshed its copy on 6 Nov 2026.