Phase 1 Safety Testing of SAR405838

Neoplasm Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636479
• Other study ID #: TED12318
• Secondary ID: 2012-000733-39U1
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2012
• Est. completion date: March 5, 2018

Study information

• Verified date: May 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• SAR405838
Pharmaceutical form: Capsule Route of administration: Oral

Locations

Country	Name	City	State
France	Investigational Site Number 250001	Villejuif
Netherlands	Investigational Site Number 528001	Amsterdam
Netherlands	Investigational Site Number 528003	Rotterdam
Netherlands	Investigational Site Number 528002	Utrecht
United States	Investigational Site Number 840001	Boston	Massachusetts
United States	Investigational Site Number 840101	Boston	Massachusetts
United States	Investigational Site Number 840002	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAR405838 Maximum tolerated dose (MTD)		Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
Primary	In MTD cohort, clinical benefit		Until disease progression
Secondary	Adverse events (eg, number of patients experiencing AEs)		Baseline to end of study
Secondary	PK parameters (Cmax, Tmax, AUC)		Baseline to end of study
Secondary	Biomarkers		Baseline to end of study
Secondary	Clinical response		Baseline to end of study
Secondary	Drug administration compliance		Baseline to end of study