Phase 1 Safety Testing of SAR405838

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01636479

First received: July 2, 2012

Last updated: January 20, 2015

Last verified: January 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Neoplasm Malignant	Drug: SAR405838	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer

Further study details as provided by Sanofi:

Primary Outcome Measures:

SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ] [ Designated as safety issue: No ]
In MTD cohort, clinical benefit [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
Clinical response [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
Drug administration compliance [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]


Estimated Enrollment:	82
Study Start Date:	July 2012
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SAR405838 SAR405838 in escalating doses	Drug: SAR405838 Pharmaceutical form: Capsule Route of administration: Oral

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479

Contacts


Contact: For site information, send an email with site number to		Contact-Us@sanofi.com

Locations


United States, Massachusetts
Investigational Site Number 840001	Recruiting
Boston, Massachusetts, United States, 02115
Investigational Site Number 840101	Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Investigational Site Number 840002	Recruiting
New York, New York, United States, 10021
France
Investigational Site Number 250001	Active, not recruiting
Villejuif, France, 94805
Netherlands
Investigational Site Number 528001	Recruiting
Amsterdam, Netherlands, 1066 CX
Investigational Site Number 528003	Recruiting
Rotterdam, Netherlands, 3075 EA
Investigational Site Number 528002	Recruiting
Utrecht, Netherlands, 3584 CX

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Clinical Sciences & Operations	Sanofi

More Information

No publications provided


Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01636479 History of Changes
Other Study ID Numbers:	TED12318, 2012-000733-39, U1111-1127-2911
Study First Received:	July 2, 2012
Last Updated:	January 20, 2015
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on March 01, 2015

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