CancerPhase 2NCT02640508

Eribulin and Lenvatinib in Advanced Solid Tumors

A Phase 2 study testing Eribulin and Lenvatinib in people with Cancer and Solid Tumor, run by Virginia G. Kaklamani at 1 site in United States.

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 overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Solid Tumor
What is being tested?: Eribulin and Lenvatinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: May 2016to 12 Jan 2023
Phase: Phase 2
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

Stage IV breast cancer, stage IV NSCLC (Non-Small Cell Lung Cancer) (, stage IV sarcoma
ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
Measurable disease
No more than 4 prior chemotherapeutic regimens for metastatic disease
Patients must be >/= 18 years.
Patients may not have received eribulin or lenvatinib previously

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Patients must have a life expectancy of greater than 12 weeks.
Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment and are considered free of disease.
Patients must have normal organ and marrow function as defined below:
Leukocytes ≥ 3,000/uL Absolute neutrophil count ≥ 1,500/uL Platelets ≥ 100,000/uL Child Pugh score ≤ 10 Patients must be able to swallow and retain oral medication. All patients must have given signed, informed consent prior to registration on study.

Who cannot join

Women who are pregnant or lactating are not eligible for study treatment.
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation.
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation. Previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration.
Lesions that have been radiated previously cannot be considered target lesions
Prior treatment related side effects must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility.
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.

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Patients with known brain metastases are NOT eligible for participation unless the brain metastases are treated (either with surgical excision, stereotactic radiosurgery or radiotherapy) and have been stable for at least 4 wks per MR performed, the patient is asymptomatic and has discontinued corticosteroids if taken for that purpose.
Patients with any of the following conditions or complications are NOT eligible for participation:
GI tract disease resulting in an inability to take oral medication
Malabsorption syndrome
Require IV alimentation
History of prior surgical procedures affecting absorption
Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
Hypersensitivity of any of the components of eribulin or lenvatinib
History of significant neurological ( no neuropathy more than grade 2) or psychiatric disorders
Significant non neoplastic liver disease (Cirrhosis, active chronic hepatitis)
Immunocompromised subjects, including patients with human immunodeficiency virus
Significant non neoplastic renal disease
Active infection requiring systemic therapy.
Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment
Prolongation of QTc interval to more than 480 milliseconds when electrolyte balance is normal
Major surgery within 4 weeks prior to first dose of the study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cancer Therapy and Research Center University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229

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About this study

Official title: Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)

The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.

Read the detailed description

This is a phase II clinical trial of the combination of eribulin, and Lenvatinib. A cycle will be defined as 21 days. Eribulin will be given on days 1 and 8 of each cycle. Lenvatinib will be given daily during each cycle.

Conditions: Cancer, Solid Tumor
Being tested: Eribulin, Lenvatinib
Medical subject headings: Neoplasms

What participants receive

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

EribulinDrug
Also called Halaven
Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.
LenvatinibDrug
Also called Lenvima
Will be taken orally at 20-24 mg daily in each 21 day cycle.

Study groups in NCT02640508
Study group	Role	What they receive
Combination Eribulin and lenvatinib	Experimental	Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle. Receives: Drug: Eribulin; Drug: Lenvatinib

What is being measured

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

Overall Response Rate of Lenvatinib and Eribulin (Phase II)
Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review.
Measured: The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months.
Progression Free Survival
Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death.
Measured: Baseline to 50 months

Secondary outcomes (2)

Overall Survival Rate
Measured: Baseline to 50 months
Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03
Adverse events are graded in the NCI CTCAE version 4.03 scale and reported by number of adverse events per grade
Measured: Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death up to 40 months.

Timeline

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

May 201612 Jan 2023

First posted29 Dec 2015 (estimated)
Study startMay 2016
Primary completion24 Nov 2020
Study completion12 Jan 2023

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02640508
Sponsor's protocol ID: CTMS 15-2139
Other IDs: HSC20150891H
Status last verified: Apr 2024
First submitted: 26 Nov 2015
Last updated: 9 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Banwait R, Ko H, Michalek J, Liu Q, Lathrop K, Bowhay-Carnes E, Fotopoulos G, Sarantopoulos J, Elledge R, Taverna J, Karnad A, Siziopikou KP, Kaklamani V. Pilot phase II study of the combination of lenvatinib (L) and eribulin (E) in advanced solid tumors. Int J Cancer. 2025 Aug 15;157(4):752-759. doi: 10.1002/ijc.35446. Epub 2025 Apr 15.
PubMed 40232157

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
ClinicalTrials.gov ID: NCT02640508
Acronym / sponsor ID: CTMS 15-2139
Conditions: Cancer, Solid Tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Virginia G. KaklamaniUniversity, hospital or other
Collaborators: Eisai Inc.
Study start: May 2016
Primary completion: 24 Nov 2020 (actual)
Study completion: 12 Jan 2023 (actual)
First posted: 29 Dec 2015 (estimated)
Results: Posted 9 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Combination Eribulin and lenvatinib	Experimental	Drug: Eribulin, Drug: LenvatinibEribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Stage IV breast cancer, stage IV NSCLC (Non-Small Cell Lung Cancer) (, stage IV sarcoma
ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
Measurable disease
No more than 4 prior chemotherapeutic regimens for metastatic disease
Patients must be >/= 18 years.

Key exclusion criteria (22 listed)

Women who are pregnant or lactating are not eligible for study treatment.
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation.
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation. Previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration.
Lesions that have been radiated previously cannot be considered target lesions
Prior treatment related side effects must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility.

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
EribulinAlso: HalavenWill be given by I.V. at 1.4 mg/m2 on day 1 and day 8.	Drug	Combination Eribulin and lenvatinib
LenvatinibAlso: LenvimaWill be taken orally at 20-24 mg daily in each 21 day cycle.	Drug	Combination Eribulin and lenvatinib

Primary outcome

Overall Response Rate of Lenvatinib and Eribulin (Phase II)
Time frame: The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months.
Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review.
Progression Free Survival
Time frame: Baseline to 50 months
Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death.

2 secondary outcomes

Overall Survival Rate
Time frame: Baseline to 50 months
Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03
Time frame: Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death up to 40 months.

Results and safety

Results posted to the registry on 9 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lenvatinib and Eribulin	29	0

Primary outcome: Overall Response Rate of Lenvatinib and Eribulin (Phase II)

Time frame: The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months.. Number. Unit: participants

Measure	Combination Eribulin and Lenvatinib n = 23
Partial Response	7
Stable Disease	13
Progression of Disease	3

Population analysed: Only 23 patients had evaluable disease as 6 subjects came off study early prior to first assessment due to toxicities.

Primary outcome: Progression Free Survival

Time frame: Baseline to 50 months. Median (Full Range). Unit: months

Measure	Combination Eribulin and Lenvatinib n = 23
Value	7.4 (1 to 47)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for all subjects from first cycle of the administration of the study drug through the end of the active study follow-up of the study during treatment up to 50 months. No subjects were escalated to a higher dose due to toxicity concerns, so all participants received the same dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Eribulin and Lenvatinib	4 of 29 (13.8%)	29 of 29 (100%)	19 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40232157Banwait R, Ko H, Michalek J, Liu Q, Lathrop K, Bowhay-Carnes E, Fotopoulos G, Sarantopoulos J, Elledge R, Taverna J, Karnad A, Siziopikou KP, Kaklamani V. Pilot phase II study of the combination of lenvatinib (L) and eribulin (E) in advanced solid tumors. Int J Cancer. 2025 Aug 15;157(4):752-759. doi: 10.1002/ijc.35446. Epub 2025 Apr 15.

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Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 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.

Virginia Kaklamani, MD principal investigator

The University of Texas Health Science Center at San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin and Lenvatinib in people with Cancer and Solid Tumor, run by Virginia G. Kaklamani at 1 site 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 10 inclusion and 22 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 9 May 2024. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 May 2024). 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?

Overall Response Rate of Lenvatinib and Eribulin (Phase II) (time frame: The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months.). 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 NCT02640508, 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 9 May 2024.