Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Adult Alveolar Soft-part Sarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Endometrial Stromal Sarcoma
Mast Cell Sarcoma
Metastatic Adult Malignant Fibrous Histiocytoma of Bone
Recurrent Adult Malignant Fibrous Histiocytoma of Bone
Recurrent Adult Soft Tissue Sarcoma
Small Intestine Leiomyosarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of MLN8237 in Advanced / Metastatic Sarcoma|
- The confirmed response rate (CR/PR) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]The overall response rate (CR + PR) will be estimated and a 90% confidence interval provided.
- PFS [ Time Frame: The time between registration to disease progression or death, assessed up to 18 months ] [ Designated as safety issue: No ]The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS, 6 month survival).
- OS [ Time Frame: The time between registration and death, assessed up to 18 months ] [ Designated as safety issue: No ]The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS and survival at specific time points will be calculated (eg, median, 1 year PFS, 6 month survival).
- Adverse events, assessed using NCI CTCAE version 4.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]Adverse events will be summarized using summary statistics and frequency tables for each separate cohort. Analyses will be descriptive in nature.
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
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).
I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients treated with alisertib (MLN8237) in each cohort.
II. To assess the adverse events associated with patients treated with MLN8237 in each cohort.
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 (i.e., week 2 of cycle 1).
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 for up to 18 months.