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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Neoplasm Malignant

Treatments

Drug: SAR405838

Drug: Pimasertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01985191

2013-002325-33

TCD13388

U1111-1144-8349 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.