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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Niacinamide

Criteria

Inclusion criteria:

• Histologically or cytologically confirmed diagnosis of a solid tumor.

• Presence of locally advanced or metastatic disease with at least one measurable lesion.

• Ability to provide written informed consent. Evidence of a personally signed informed consent.

Exclusion criteria:

• Age <18 years.

• Eastern Cooperative Oncology Group performance status of >1.

• Inadequate functions of bone marrow, liver, and kidney.

• Positive pregnancy test in women of child-bearing potential.

• Pregnancy or breast-feeding.

• Extensive prior radiotherapy.

• The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination.

• Prior history of myositis or rhabdomyolysis.

• Recent major surgery or trauma, unhealing/open wounds.

• The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study.

• The patient has a baseline corrected QT interval (QTc) >480 ms or left ventricular ejection fraction (LVEF) <50% or less than the lower limit of normal.

• The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations.

• Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.

• 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 history of acute pancreatitis.

• Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.