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Advanced Solid TumorPhase 1NCT01106248

QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

A Phase 1 study testing Eribulin Mesylate in people with Advanced Solid Tumor, run by Eisai Limited at 2 sites in France.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis. Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Eribulin Mesylate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesFrance
Study dates
Mar 2009to Sep 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
  • Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy </= Grade 2 and alopecia.
  • Age >/= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Patients must have a sinus rhythm and QRS < 120msec.
  • Adequate renal function as evidenced by serum creatinine </= 2.0 mg/dL or calculated creatinine clearance >/= 40 mL/min per the Cockcroft and Gault formula.
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  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >/= 1.5 x 10^9/L, hemoglobin >/= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin >/= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) </= 3 x ULN (in the case of liver metastases </= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
  • Patients willing and able to comply with the study protocol for the duration of the study.
  • 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 any of the following treatments within the specified period before start of treatment with eribulin mesylate:
  • Chemotherapy, radiation or biological therapy within three weeks
  • Hormonal therapy within one week
  • Any investigational drug within four weeks
  • Have had radiation therapy encompassing > 30% of bone marrow.
  • Have received prior treatment with mitomycin C or nitrosourea.
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  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
  • Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g. radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
  • Patients with meningeal carcinomatosis.
  • Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).
  • Patients with marked baseline prolongation of QT/QTc interval (QTc interval > 500 msec).
  • Patients with a history of additional risk factors for Torsades des pointes (e.g., heart failure, cardiac ischemia, recent Myocardial Infarction (MI), family history of Long QT Syndrome).
  • Patients with uncontrolled metabolic disorders (e.g hypokalemia, hypercalcemia and hypomagnesemia) at entry to the study.
  • Patients treated with antiarrythmic drugs or other medications that prolong the QT/QTc, that cannot be discontinued prior to entry into the study phase.
  • Patients with implantable pacemaker or automatic implantable cardioverter defibrillator (AICD).
  • .Bradycardia (defined as </= 50 beats/minute).
  • Personal history of unexplained syncope within the last year prior to entry into the study.
  • Patients with other significant disease or disorders that, in the Investigator's opinion, should exclude the patient from the study.
  • Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.
  • Women who are pregnant or breast-feeding; 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. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Severe/uncontrolled intercurrent illness/infection.
  • Patients with organ allografts requiring immunosuppression.
  • Patients with known positive HIV status.
  • Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >/= 5 years previously with no subsequent evidence of recurrence.
  • Patients with pre-existing neuropathy > Grade 2.
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
  • Patients who participated in a prior eribulin mesylate clinical trial.
  • Patients with pericardial effusion or pericardial metastases.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Medicale

    Dunkirk, *CS, 44229

  • Service d'Oncologie

    Dunkirk, *CS, 44229

Other trials in France

About this study

Official title: An Open-Label, Multicenter, Single Arm QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.

Read the detailed description

This is an open-label, multicenter, single arm QT Interval prolongation study of eribulin mesylate (E7389) in patients with advanced solid tumors.

Being tested
Eribulin Mesylate
Keywords
tumor
Medical subject headings
Neoplasms

What participants receive

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

  • Eribulin MesylateDrug

    1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

Study groups in NCT01106248
Study groupRoleWhat they receive
Eribulin MesylateOtherNot described
Receives: Drug: Eribulin Mesylate

What is being measured

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

  1. Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.

    The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.

    Measured: 48 hours postdose after Day 1 and after Day 8

Secondary outcomes (4)

  1. Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)

    Pharmacokinetic profile of eribulin mesylate (Cmax).

    Measured: Days 1 and 8

  2. To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.

    Measured: 21 day cycle

  3. To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.

    Measured: 21 day cycle

  4. Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).

    Pharmacokinetic profile of eribulin mesylate (tmax).

    Measured: Days 1 and 8

Timeline

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

  1. First posted19 Apr 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionSep 2010

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106248
Sponsor's protocol ID
E7389-E044-110
Status last verified
Mar 2012
First submitted
14 Apr 2010
Last updated
13 Apr 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eribulin Mesylate in people with Advanced Solid Tumor, run by Eisai Limited at 2 sites in France.

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 28 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 13 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 2 sites in France. 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 13 Apr 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?

Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing. (time frame: 48 hours postdose after Day 1 and after Day 8). 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 NCT01106248.

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 13 Apr 2012.

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