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

Completed

Conditions: advanced cancer
10027656

Registration Number: NL-OMON44662

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 57

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. At a specified dose level, enrollment will be limited to dedifferenitated liposarcoma, and for the MTD cohort, 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 pregancy test
* Pregnancy or breast-feeding.
*Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) prior to study treatment or 5 halflives 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* SAR405838 Maximum Tolerated Dose (MTD)<br /><br>* In MTD cohort, clinical benefit</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Adverse events (eg, number of patients experience adverse events)<br /><br>* PK parameters (Cmax, Tmax, AUC)<br /><br>* Biomarkers<br /><br>* Clinical Response<br /><br>* Drug administration compliance</p><br>