Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma
This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the response rate (complete response [CR] + partial response [PR]) assessed
for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort
2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known
as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral
nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients
treated with MLN8237 (alisertib) in each cohort.
II. To assess the adverse events associated with patients treated with MLN8237 in each
cohort.
TERTIARY OBJECTIVES:
I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre-
and post-treatment tumor biopsies.
II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine (FLT)-positron
emission tomography (PET) uptake at baseline versus after one week of treatment (ie, week 2
of cycle 1).
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 18 months.
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