Phase 1 Safety Testing of SAR405838

Status: Recruiting
Phase:
Diagnosis: Sarcoma
NCT ID: NCT01636479 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-134

 

Primary Objectives: - To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). - To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: - Pharmacokinetic (PK) profile of SAR405838. - Biomarkers in association with SAR405838. - Anti-tumor activity in response to SAR405838. - Food effect on SAR405838 PK.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Andrew J. Wagner, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Edwin Choy, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org
Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion criteria: - Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled. - For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included. - Presence of locally advanced or metastatic disease with at least one measurable lesion. Exclusion criteria: - Age <18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of >1. - Life expectancy <12 weeks. - Unstable brain or leptomeningeal disease based on history and physical examination. - Inadequate organ functions, positive pregnancy test. - Pregnancy or breast-feeding. - Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment. - Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods. - Recent (3 months) history of acute pancreatitis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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