Pharmaceutical form: Capsule Route of administration: Oral

SAR405838

Clinical Sciences & Operations

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.

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

Phase 1 Safety Testing of SAR405838

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

Sanofi

SAR405838 and pimasertib in escalating doses

Pharmaceutical form:capsule

Route of administration: oral

Pharmaceutical form: capsule

Route of administration: oral

Pimasertib

Primary Objectives:

To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.

To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.

Secondary Objectives:

To characterize the pharmacokinetic profile of SAR405838 and pimasertib.

To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.

To characterize genetic status in tumor tissue and circulating tumor DNA.

The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Safety Testing of SAR405838	NCT01636479	Neoplasm Malign...	SAR405838	18 Years -	Sanofi
A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients	NCT01985191	Neoplasm Malign...	SAR405838 Pimasertib	18 Years -	Sanofi

Spots Global Cancer Trial Database for sar405838

Every month we try and update this database with for sar405838 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for sar405838

Every month we try and update this database with for sar405838 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar405838 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.