Phase 1 Safety Testing of SAR405838 | NCT01636479

Studies
Phase 1 Safety Testing of SAR405838

NCT01636479

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 17, 2018Actual

Enrollment

77Actual

Phase

Phase 1

Conditions

Neoplasm Malignant

Interventions

SAR405838

Countries

United States
France
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-000733-39
U1111-1127-2911	Other Identifier	UTN

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2012

Primary Completion Date

Mar 5, 2018Actual

Completion Date

Mar 5, 2018Actual

First Submitted Date

Jul 2, 2012

First Submission Date that Met QC Criteria

Jul 5, 2012

First Posted Date

Jul 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2018

Last Update Posted Date

May 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary Objectives:

To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

Pharmacokinetic (PK) profile of SAR405838.
Biomarkers in association with SAR405838.
Anti-tumor activity in response to SAR405838.
Food effect on SAR405838 PK.
Compliance with SAR405838 treatment.
Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Detailed Description

Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Label	Type	Description	Intervention Names
SAR405838	Experimental	SAR405838 in escalating doses	Drug: SAR405838

Name	Type	Description	Arm Group Labels	Other Names
SAR405838	Drug	Pharmaceutical form: Capsule Route of administration: Oral	SAR405838

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SAR405838 Maximum tolerated dose (MTD)		Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
In MTD cohort, clinical benefit		Until disease progression

Secondary Outcomes

Measure	Description	Time Frame
Adverse events (eg, number of patients experiencing AEs)		Baseline to end of study
PK parameters (Cmax, Tmax, AUC)		Baseline to end of study
Biomarkers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
Presence of locally advanced or metastatic disease with at least one measurable lesion.

Exclusion criteria:

Age <18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of >1.
Life expectancy <12 weeks.
Unstable brain or leptomeningeal disease based on history and physical examination.
Inadequate organ functions, positive pregnancy test.
Pregnancy or breast-feeding.
Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
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 (3 months) history of acute pancreatitis.

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840101		Boston	Massachusetts	02114	United States
Investigational Site Number 840001

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28324749	Derived	de Jonge M, de Weger VA, Dickson MA, Langenberg M, Le Cesne A, Wagner AJ, Hsu K, Zheng W, Mace S, Tuffal G, Thomas K, Schellens JH. A phase I study of SAR405838, a novel human double minute 2 (HDM2) antagonist, in patients with solid tumours. Eur J Cancer. 2017 May;76:144-151. doi: 10.1016/j.ejca.2017.02.005. Epub 2017 Mar 17.