Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma (NCT03526679) | Clinical Trial Compass
CompletedPhase 1/2
Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma
Taiwan30 participantsStarted 2018-07-12
Plain-language summary
This study is designed to test the safety and efficacy of the combination of lenvatinib, a drug that can inhibit the growth of supplying vessels around the tumors, and eribulin, a chemotherapy drug that targets the cancer cell during mitosis, in inoperable or metastatic adipocytic sarcoma and leiomyosarcoma.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A histological confirmed adipocytic sarcoma (dedifferentiated, myxoid, or pleomorphic) or leiomyosarcoma that is either inoperable locally advanced or metastatic
✓. Advanced adipocytic sarcoma and leiomyosarcoma who have received no more than 2 lines of systemic chemotherapy in the advanced setting (not including adjuvant chemotherapy).
✓. At least one measurable tumor according to RECIST 1.1. If the measurable lesion has previously received radiotherapy, the tumor must be a progressive lesion after radiotherapy.
✓. ECOG PS 0 or 1 or Karnofsky performance status (KPS) ≥ 70
✓. Patients must have adequate organ function and marrow reserve measured within 14 days prior to randomization as defined below:
✓. Age 20 or older.
✓. Patient's life expectancy is more than 3 months
✓. All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.
Exclusion criteria
✕. Patients who had received lenvatinib or eribulin treatment
✕. Patients who had leptomeningeal metastasis, either diagnosed by brain imaging study or confirmed by cerebrospinal fluid cytology examination (patients with brain metastasis that are under control is eligible).
✕. Patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction.
What they're measuring
1
The Objective Response Rate (ORR) Based on RECIST 1.1
✕. Patients with uncontrollable hypertension (defined as systolic blood pressure over 140mmHg and/or diastolic pressure over 90mmHg despite anti-hypertensive medications)
✕. Patients with the following cardiac disease
✕. Bleeding subjects at risk for severe hemorrhage.
✕. Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction.
✕. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.