Phase 1 Safety Testing of SAR405838

Completed · Phase 1

Conditions studied: Neoplasm Malignant

In brief

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. * Compliance with SAR405838 treatment. * Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Key facts

Study ID

NCT01636479

Run by

Sanofi

People needed

77

Starts

2012-07-13

Expected to finish

2018-03-05

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840101 — Boston, Massachusetts, United States
• Investigational Site Number 840001 — Boston, Massachusetts, United States
• Investigational Site Number 840002 — New York, New York, United States
• Investigational Site Number 250001 — Villejuif, France
• Investigational Site Number 528001 — Amsterdam, Netherlands
• Investigational Site Number 528003 — Rotterdam, Netherlands
• Investigational Site Number 528002 — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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