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

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: SAR405838; Drug: Pimasertib

• Registration Number: NCT01985191
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Pimasertib	SAR405838 and pimasertib in escalating doses
Arm 1	SAR405838	SAR405838 and pimasertib in escalating doses

Primary Outcome Measures

Name	Time	Method
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities	6 weeks for each patient at each dose level
Changes of tumor dimension by imaging	At least 3 months for each patient

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters for both SAR405838 (pimasertib): area under the curve (AUC), etc.	3 months for each patient
Biomarker changes in response to SAR405838 (pimasertib) treatment	3 months for each patient
Genetic status in tumor tissue	Baseline
Change of the genetic status of circulating tumor DNA	Baseline and until disease progression
Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events	Throughout the study
Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)	3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)	3 months for each patient

Trial Locations

Locations (4)

Investigational Site Number 528002; 🇳🇱 Utrecht, Netherlands

Investigational Site Number 250001; 🇫🇷 Villejuif Cedex, France

Investigational Site Number 528003; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 528001; 🇳🇱 Amsterdam, Netherlands