Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Phase 1 Safety Testing of SAR405838
Phase 1 Safety Testing of SAR405838

NCT01636479

CompletedPhase 1

Sponsor: Sanofi

Conditions: Neoplasm Malignant

Interventions: SAR405838

Countries: United States, France, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (7)
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Villejuif, France
  • Amsterdam, Netherlands
  • Rotterdam, Netherlands
  • Utrecht, Netherlands