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Eribulin and Lenvatinib in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02640508
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor Drug: Eribulin Drug: Lenvatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination Eribulin and lenvatinib
Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.
Drug: Eribulin
Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.
Other Name: Halaven

Drug: Lenvatinib
Will be taken orally at 20-24 mg daily in each 21 day cycle.
Other Name: Lenvima




Primary Outcome Measures :
  1. Overall response rate of lenvatinib and eribulin [ 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. GI tract disease resulting in an inability to take oral medication
    2. Malabsorption syndrome
    3. Require IV alimentation
    4. History of prior surgical procedures affecting absorption
    5. Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
    6. Hypersensitivity of any of the components of eribulin or lenvatinib
    7. History of significant neurological ( no neuropathy more than grade 2) or psychiatric disorders
    8. Significant non neoplastic liver disease (Cirrhosis, active chronic hepatitis)
    9. Immunocompromised subjects, including patients with human immunodeficiency virus
    10. Significant non neoplastic renal disease
    11. Active infection requiring systemic therapy.
    12. 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
    13. Prolongation of QTc interval to more than 480 milliseconds when electrolyte balance is normal
    14. Major surgery within 4 weeks prior to first dose of the study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640508


Locations
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United States, Texas
Cancer Therapy and Research Center University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Virginia G. Kaklamani
Eisai Inc.
Investigators
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Principal Investigator: Virginia Kaklamani, MD University of Texas Health Science Center San Antonio

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Responsible Party: Virginia G. Kaklamani, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02640508     History of Changes
Other Study ID Numbers: CTMS 15-2139
HSC20150891H ( Other Identifier: University of Texas Health Science Center- San Antonio )
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action