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 |
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.
- 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.
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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