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.
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:
GI tract disease resulting in an inability to take oral medication
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.
All locations for NCT02640508
United States (1)
Cancer Therapy and Research Center University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
View full eligibility
Tris trial is registered with FDA with number: NCT02640508. The sponsor of the trial is Virginia G. Kaklamani and it is looking for 32 volunteers for the current phase.
Official trial title: Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
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