CancerPhase 1NCT00326950
Phase I Clinical Study of E7389
A Phase 1 study testing E7389 in people with Cancer, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Cancer
- 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
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2006to Feb 2008
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed solid tumors.
- Patients who have progressed on or following standard therapy and with no other treatment options.
- Patients aged 20-74 when they give informed consent.
- Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Patients who can stay at the hospital from the start of the study drug treatment to 2 weeks of the first cycle.
- Patients having adequate function of major organs (bone marrow, liver, kidney and lungs):
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- Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4) Aspartate aminotransferase [AST] 2.5 times the upper limits of normal (ULN) in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (5) Alanine aminotransferase [ALT] 2.5 times ULN in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (6) Total bilirubin 1.5 times ULN in institute (7) Serum creatinine 1.5 times ULN in institute (8) Pulse oximeter oxygen saturation 90%
- 7. Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by the prior therapy or could influence the safety evaluation of the study drug.
- The withdrawal periods required from the completion of the prior therapy to the start of the study drug therapy are as follows:
- Chemotherapy (excluding oral 5-FU and molecular target drugs), surgical therapy, other study drugs: 4 weeks
- Nitrosourea agents, mitomycin C: 6 weeks
- Radiotherapy, endocrinotherapy, immunotherapy, oral 5-FU, molecular target drugs, blood transfusion, blood products, G-CSF and other hematopoietic factors: 2 weeks
- 8. Patients who give written informed consent.
- 9. Patients with an expected survival of longer than 3 months from the start of the study drug therapy.
Who cannot join
- Patients with systemic infection with a fever (38°C).
- Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage.
- Patients with brain metastasis with clinical symptoms.
- Patients with serious complications: (1) Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension) (2) Patients with myocardial infarction within 6 months prior to study entry (3) Patients with a complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and pulmonary fibrosis (5) Patients with a bleeding tendency
- Women who are pregnant or breastfeeding, or premenopausal women of childbearing potential.
- Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Premenopausal women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test, or have not agreed to use adequate measures of contraception.
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- 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 tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus surface antigen (HBsAg).
- Patients who need continuous systemic steroid therapy during the study period.
- Patients who need continuous use of phenytoin, carbamazepine, rifampicin and/or barbiturate which induces cytochrome P450 (CYP3A4), a drug-metabolizing enzyme, during the study period.
- Patients who have received extensive radiation therapy (30% or more of bone marrow).
- Patients who refused to receive a supportive therapy of blood transfusion by suppressing bone marrow.
- Patients who are participating in other clinical studies.
- Patients whom the investigator or subinvestigator has judged inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study of E7389 in Patients With Solid Tumors
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.
- Conditions
- Cancer
- Being tested
- E7389
- Keywords
- Cancer, Tumors, Phase I, E7389
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7389Drug
E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E7389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)
DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
Measured: 3 weeks
Maximum Tolerated Dose (MTD)
MTD was the lowest dose at which a dose limiting toxicity occurred.
Measured: 3 Weeks
Secondary outcomes (1)
Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomio Nakamura, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326950
- Sponsor's protocol ID
- E7389-J081-105
- Status last verified
- Mar 2012
- First submitted
- 16 May 2006
- Last updated
- 8 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mukohara T, Nagai S, Mukai H, Namiki M, Minami H. Eribulin mesylate in patients with refractory cancers: a Phase I study. Invest New Drugs. 2012 Oct;30(5):1926-33. doi: 10.1007/s10637-011-9741-2. Epub 2011 Sep 2.
PubMed 21887501
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of E7389 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00326950
- Acronym / sponsor ID
- E7389-J081-105
- Conditions
- Cancer
- Keywords
- Cancer, Tumors, Phase I, E7389
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 May 2006 (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.
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E7389 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with histologically or cytologically confirmed solid tumors.
- Patients who have progressed on or following standard therapy and with no other treatment options.
- Patients aged 20-74 when they give informed consent.
- Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Patients who can stay at the hospital from the start of the study drug treatment to 2 weeks of the first cycle.
Key exclusion criteria (14 listed)
- Patients with systemic infection with a fever (38°C).
- Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage.
- Patients with brain metastasis with clinical symptoms.
- Patients with serious complications: (1) Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension) (2) Patients with myocardial infarction within 6 months prior to study entry (3) Patients with a complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and pulmonary fibrosis (5) Patients with a bleeding tendency
- Women who are pregnant or breastfeeding, or premenopausal women of 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 |
|---|---|---|
| E7389E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2. | Drug | 1 |
Primary outcome
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)
Time frame: 3 weeks
DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
Maximum Tolerated Dose (MTD)
Time frame: 3 Weeks
MTD was the lowest dose at which a dose limiting toxicity occurred.
1 secondary outcome
Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21887501Mukohara T, Nagai S, Mukai H, Namiki M, Minami H. Eribulin mesylate in patients with refractory cancers: a Phase I study. Invest New Drugs. 2012 Oct;30(5):1926-33. doi: 10.1007/s10637-011-9741-2. Epub 2011 Sep 2.
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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.
Tomio Nakamura study director
Eisai Co., Ltd.
1 site 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 Co., Ltd. at 1 site in Japan.
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 14 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT) (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT00326950, which also lists 1 linked publication.
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 8 Mar 2012.