CancerPhase 1NCT00459823
A Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours
A Phase 1 study testing E7107 in people with Cancer, run by Eisai Limited at 2 sites in 2 countries.
Trial summary
Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- E7107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2007to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
- Patients with histologically and/or cytologically confirmed solid tumours who have progressed after receiving approved therapies for their disease and for whom no curative therapies are available.
- Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued for at least two weeks previously. All acute toxicities related to these treatments must have resolved.
- Aged >= 18 years.
- ECOG performance status score of 0 or 1.
- Written informed consent prior to any study specific screening procedures, which will include voluntary additional consent to provide specimens specifically for pharmacogenomic analysis, with the understanding that the patient may withdraw consent at any time without prejudice.
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- Willing and able to comply with the protocol for the duration of the study.
- Anticipated life expectancy > three months.
- After MTD has been reached: patients must have measurable disease according to RECIST criteria.
Who cannot join
- Patients with the following characteristics will not be eligible for the study:
- Symptomatic or progressive brain tumours or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.
- Any of the following laboratory parameters:
- haemoglobin < 9 g/dL (5.6 mM)
- neutrophils <1.5 x 10^9/L
- platelets <100 x 10^9/L
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- serum bilirubin >25 ìM (1.5 mg/dL)
- liver function tests (defined as AST and ALT) with values >3 x ULN (5 x ULN if liver metastases are present)
- serum creatinine > 105µM (or >1.5 mg/L) or creatinine clearance < 40 mL/min
- Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
- Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class III according to NYHA classification) including a myocardial infarction within six months of study start.
- Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants.
- History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
- Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; peri-menopausal women must have been amenorrheic for at least 12 months, otherwise pregnancy test is required).
- Fertile persons who are not willing to use adequate contraception (defined as two forms of contraception including a barrier method).
- Patients with a marked screening or baseline prolongation of QT/QTc interval (i.e., repeated demonstration of a QTc interval > 450 msec); a history of additional factors of TdP (i.e., heart failure, hypokalaemia, family history of Long QT Syndrome).
- Legal incapacity.
- After MTD has been reached: Second malignancy within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Department of Medical Oncology, Erasmus University Medical Centre
Rotterdam
Spain1 site
Medical Oncology Service. Vall d'Hebron University Hospital
Barcelona, 08035
About this study
Official title: A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours
Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.
- Conditions
- Cancer
- Being tested
- E7107
- Keywords
- Cancer, solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7107Drug
E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E7107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine MTD of E7107. Safety and tolerability.
Measured: Every six weeks.
Secondary outcomes (1)
Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect.
Measured: Every 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jantien Wanders, M.D., Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459823
- Sponsor's protocol ID
- E7107-E044-102
- Status last verified
- Mar 2009
- First submitted
- 11 Apr 2007
- Last updated
- 24 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT00459823
- Acronym / sponsor ID
- E7107-E044-102
- Conditions
- Cancer
- Keywords
- Cancer, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2009 (estimated)
- First posted
- 13 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.
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: E7107 |
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 meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
- Patients with histologically and/or cytologically confirmed solid tumours who have progressed after receiving approved therapies for their disease and for whom no curative therapies are available.
- Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued for at least two weeks previously. All acute toxicities related to these treatments must have resolved.
- Aged >= 18 years.
- ECOG performance status score of 0 or 1.
Key exclusion criteria (18 listed)
- Symptomatic or progressive brain tumours or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.
- Any of the following laboratory parameters:
- Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
- Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class III according to NYHA classification) including a myocardial infarction within six months of study start.
- Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants.
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 |
|---|---|---|
| E7107E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days. | Drug | 1 |
Primary outcome
To determine MTD of E7107. Safety and tolerability.
Time frame: Every six weeks.
1 secondary outcome
Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect.
Time frame: Every 21 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
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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.
Jantien Wanders, M.D. study director
Eisai Limited
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E7107 in people with Cancer, run by Eisai Limited at 2 sites in 2 countries.
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 18 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: paused, as of the sponsor's last update on 24 Mar 2009. 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 Netherlands, Spain. 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?
Results are not available in the source record.
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?
To determine MTD of E7107. Safety and tolerability. (time frame: Every six 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 24 Mar 2009.