## Protocol Section
### Identification Module
**NCT ID:** NCT01636479

**Brief Title:** Phase 1 Safety Testing of SAR405838

**Official Title:** A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer

#### Organization Study ID Info
**ID:** TED12318
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2012-000733-39
**Domain:** UTN
**ID:** U1111-1127-2911
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2018-03-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2018-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-05

**Type:** ACTUAL

#### Start Date
**Date:** 2012-07-13

**Status Verified Date:** 2018-05

#### Study First Post Date
**Date:** 2012-07-10
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-02
**Study First Submit QC Date:** 2012-07-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Neoplasm Malignant

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 77

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** SAR405838 in escalating doses

**Intervention Names:**

- Drug: SAR405838

**Label:** SAR405838

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SAR405838

**Description:** Pharmaceutical form: Capsule Route of administration: Oral

**Name:** SAR405838

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** SAR405838 Maximum tolerated dose (MTD)

**Time Frame:** Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule

**Measure:** In MTD cohort, clinical benefit

**Time Frame:** Until disease progression

#### Secondary Outcomes

**Measure:** Adverse events (eg, number of patients experiencing AEs)

**Time Frame:** Baseline to end of study

**Measure:** PK parameters (Cmax, Tmax, AUC)

**Time Frame:** Baseline to end of study

**Measure:** Biomarkers

**Time Frame:** Baseline to end of study

**Measure:** Clinical response

**Time Frame:** Baseline to end of study

**Measure:** Drug administration compliance

**Time Frame:** Baseline to end of study

### 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Investigational Site Number 840101

**State:** Massachusetts

**Zip:** 02114

**Location 2:**

**City:** Boston

**Country:** United States

**Facility:** Investigational Site Number 840001

**State:** Massachusetts

**Zip:** 02115

**Location 3:**

**City:** New York

**Country:** United States

**Facility:** Investigational Site Number 840002

**State:** New York

**Zip:** 10021

**Location 4:**

**City:** Villejuif

**Country:** France

**Facility:** Investigational Site Number 250001

**Zip:** 94805

**Location 5:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Investigational Site Number 528001

**Zip:** 1066 CX

**Location 6:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Investigational Site Number 528003

**Zip:** 3075 EA

**Location 7:**

**City:** Utrecht

**Country:** Netherlands

**Facility:** Investigational Site Number 528002

**Zip:** 3584 CX

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 28324749

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
