NCT01636479

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

July 13, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

5.6 years

First QC Date

July 2, 2012

Last Update Submit

May 16, 2018

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

  • 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 (5)

  • Adverse events (eg, number of patients experiencing AEs)

    Baseline to end of study

  • PK parameters (Cmax, Tmax, AUC)

    Baseline to end of study

  • Biomarkers

    Baseline to end of study

  • Clinical response

    Baseline to end of study

  • Drug administration compliance

    Baseline to end of study

Study Arms (1)

SAR405838

EXPERIMENTAL

SAR405838 in escalating doses

Drug: SAR405838

Interventions

SAR405838DRUG

Pharmaceutical form: Capsule Route of administration: Oral

SAR405838

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigational Site Number 840101

Boston, Massachusetts, 02114, United States

Location

Investigational Site Number 840001

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 840002

New York, New York, 10021, United States

Location

Investigational Site Number 250001

Villejuif, 94805, France

Location

Investigational Site Number 528001

Amsterdam, 1066 CX, Netherlands

Location

Investigational Site Number 528003

Rotterdam, 3075 EA, Netherlands

Location

Investigational Site Number 528002

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • 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: 28324749DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

SAR405838

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 10, 2012

Study Start

July 13, 2012

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

FR(1)US(3)NL(3)