Phase 1 Safety Testing of SAR405838



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/19/2018
Start Date:July 13, 2012
End Date:March 5, 2018

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A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer

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.

Total duration of study participation for each patient will be one month screening followed
by treatment until precluded by toxicity, noncompliance, progression, or death.

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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