Phase 1 Safety Testing of SAR405838

Sanofi

Status and phase

Completed

Phase 1

Conditions

Neoplasm Malignant

Treatments

Drug: SAR405838

Study type

Interventional

Funder types

Industry

Identifiers

NCT01636479

TED12318

2012-000733-39

U1111-1127-2911 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.