Alisertib in Treating Patients With Advanced or Metastatic Sarcoma (NCT01653028) | Clinical Trial Compass
CompletedPhase 2
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
United States72 participantsStarted 2012-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed sarcoma that is metastatic and/or locally advanced or locally recurrent and unresectable; confirmation of pathologic diagnosis will be performed at the registering site; patients will been rolled on one of five cohorts of the study:
* Cohort 1: liposarcoma
* Cohort 2: leiomyosarcoma (non-uterine)
* Cohort 3: undifferentiated sarcoma (including malignant fibrous histiocytoma and myxofibrosarcoma)
* Cohort 4: malignant peripheral nerve sheath tumor
* Cohort 5: other sarcomas
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1; note: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Any number of prior therapies is permitted; note: the last dose of systemic therapy (including tyrosine kinase inhibitors) must have been given \>= 4 weeks prior to initiation of study therapy; patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* …
What they're measuring
1
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.