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

NCT ID: NCT01985191

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

SAR405838 and pimasertib in escalating doses

Group Type: EXPERIMENTAL

SAR405838

Intervention Type: DRUG

Pharmaceutical form:capsule

Route of administration: oral

Pimasertib

Intervention Type: DRUG

Pharmaceutical form: capsule

Route of administration: oral

Interventions

SAR405838

Pharmaceutical form:capsule

Route of administration: oral

Intervention Type: DRUG

Pimasertib

Pharmaceutical form: capsule

Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 250001

Villejuif, , France

Investigational Site Number 528001

Amsterdam, , Netherlands

Investigational Site Number 528003

Rotterdam, , Netherlands

Investigational Site Number 528002

Utrecht, , Netherlands

Countries

France; Netherlands

References

de Weger VA, de Jonge M, Langenberg MHG, Schellens JHM, Lolkema M, Varga A, Demers B, Thomas K, Hsu K, Tuffal G, Goodstal S, Mace S, Deutsch E. A phase I study of the HDM2 antagonist SAR405838 combined with the MEK inhibitor pimasertib in patients with advanced solid tumours. Br J Cancer. 2019 Feb;120(3):286-293. doi: 10.1038/s41416-018-0355-8. Epub 2018 Dec 26.

Reference Type: DERIVED

PMID: 30585255 (View on PubMed)

Other Identifiers

2013-002325-33

Identifier Type: -

Identifier Source: secondary_id

U1111-1144-8349

Identifier Type: OTHER

Identifier Source: secondary_id

TCD13388

Identifier Type: -

Identifier Source: org_study_id