NCT01985191

A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR405838	Pharmaceutical form:capsule Route of administration: oral
DRUG	Pimasertib	Pharmaceutical form: capsule Route of administration: oral

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2013-11-15
• Last updated: 2016-02-25

Locations

4 sites across 2 countries: France, Netherlands