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Spots Global Cancer Trial Database for A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

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

Study ID: NCT01985191

Interventions

SAR405838
Pimasertib

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Investigational Site Number 250001, Villejuif Cedex, , France

Investigational Site Number 528001, Amsterdam, , Netherlands

Investigational Site Number 528003, Rotterdam, , Netherlands

Investigational Site Number 528002, Utrecht, , Netherlands

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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