NCT01653028

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Myxofibrosarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Leiomyosarcoma
• Recurrent Liposarcoma
• Recurrent Malignant Peripheral Nerve Sheath Tumor
• Recurrent Undifferentiated Pleomorphic Sarcoma
• Stage III Soft Tissue Sarcoma AJCC v7
• Stage IV Soft Tissue Sarcoma AJCC v7

Interventions

Type	Name	Description
DRUG	Alisertib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-08-22
• Primary completion: 2015-08-02
• First posted: 2012-07-30
• Last updated: 2017-11-30
• Results posted: 2016-12-28

Locations

235 sites across 1 country: United States