Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01418677
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
A Phase 1 study testing E7389 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Eisai Inc. at 9 sites in United States.
Trial summary
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- E7389
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2011to May 2015
- 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
- Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
- Renal function must fall into one of the following categories:
- Normal function - creatinine clearance greater than or equal to 80 mL/min.
- Moderate impairment - creatinine clearance >30 to 50 mL/min.
- Severe impairment - creatinine clearance 15 to less than 30 mL/min.
- Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times the ULN (in the case of liver metastasis less than or equal to 5 times ULN). In the case ALP >3 times the ULN (in the absence of liver metastasis) or >5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP.
Who cannot join
- Subjects with mild renal impairment (creatinine clearance greater than 50 to less than 80 mL/min).
- Subjects with end stage renal disease (creatinine clearance less than 15 mL/min or on dialysis).
- Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives.
- Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment.
- Radiation therapy encompassing >30 % of bone marrow.
- Subjects with organ allografts requiring immunosuppression.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Atlanta, Georgia
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
New Brunswick, New Jersey
Study site
San Antonio, Texas
Study site
St Louis, Missouri
Study site
The Bronx, New York
About this study
Official title: An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
- Being tested
- E7389
- Keywords
- Unspecified Advance Solid Tumor, Protocol Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7389Drug
Also called Halaven
Severe renal impairment-the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1).
E7389Drug
Also called Halaven
Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
E7389Drug
Also called Halaven
Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Not described Receives: Drug: E7389 |
| Cohort 2 | Active comparator | Not described Receives: Drug: E7389 |
| Cohort 3 | Active comparator | Not described Receives: Drug: E7389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.
Measured: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of HALAVEN in subjects with moderate or severe renal impairment, as well as in those with normal renal function.
Safety data that will be evaluated include adverse events, clinical laboratory results, physical examination results, ECG, and vital signs
Measured: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418677
- Sponsor's protocol ID
- E7389-A001-106
- Status last verified
- May 2016
- First submitted
- 1 Aug 2011
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan AR, Sarantopoulos J, Lee L, Reyderman L, He Y, Olivo M, Goel S. Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function. Cancer Chemother Pharmacol. 2015 Nov;76(5):1051-61. doi: 10.1007/s00280-015-2878-5. Epub 2015 Oct 3.
PubMed 26433580
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01418677
- Acronym / sponsor ID
- E7389-A001-106
- Keywords
- Unspecified Advance Solid Tumor, Protocol Specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Aug 2011 (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.
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: E7389 |
| Cohort 2 | Active comparator | Drug: E7389 |
| Cohort 3 | Active comparator | Drug: E7389 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
- Renal function must fall into one of the following categories:
- Normal function - creatinine clearance greater than or equal to 80 mL/min.
- Moderate impairment - creatinine clearance >30 to 50 mL/min.
- Severe impairment - creatinine clearance 15 to less than 30 mL/min.
Key exclusion criteria (6 listed)
- Subjects with mild renal impairment (creatinine clearance greater than 50 to less than 80 mL/min).
- Subjects with end stage renal disease (creatinine clearance less than 15 mL/min or on dialysis).
- Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives.
- Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment.
- Radiation therapy encompassing >30 % of bone marrow.
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 |
|---|---|---|
| E7389Also: HalavenSevere renal impairment-the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1). | Drug | Cohort 1 |
| E7389Also: HalavenModerate renal impairment-HALAVEN will be dosed at 1.4 mg/m2. | Drug | Cohort 2 |
| E7389Also: HalavenNormal renal function-HALAVEN will be dosed at 1.4 mg/m2. | Drug | Cohort 3 |
Primary outcome
To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
Time frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of HALAVEN in subjects with moderate or severe renal impairment, as well as in those with normal renal function.
Time frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 26433580Tan AR, Sarantopoulos J, Lee L, Reyderman L, He Y, Olivo M, Goel S. Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function. Cancer Chemother Pharmacol. 2015 Nov;76(5):1051-61. doi: 10.1007/s00280-015-2878-5. Epub 2015 Oct 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Unspecified Adult Solid Tumor, Protocol Specific, run by Eisai Inc. at 9 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 6 inclusion and 6 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer. (time frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.). 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 NCT01418677, 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 17 May 2016.