Phase 1 Safety Testing of SAR405838
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01636479 |
Recruitment Status :
Completed
First Posted : July 10, 2012
Last Update Posted : May 17, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasm Malignant | Drug: SAR405838 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | July 13, 2012 |
Actual Primary Completion Date : | March 5, 2018 |
Actual Study Completion Date : | March 5, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: SAR405838
SAR405838 in escalating doses
|
Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral |
- SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ]
- Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ]
- PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ]
- Biomarkers [ Time Frame: Baseline to end of study ]
- Clinical response [ Time Frame: Baseline to end of study ]
- Drug administration compliance [ Time Frame: Baseline to end of study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636479
United States, Massachusetts | |
Investigational Site Number 840101 | |
Boston, Massachusetts, United States, 02114 | |
Investigational Site Number 840001 | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Investigational Site Number 840002 | |
New York, New York, United States, 10021 | |
France | |
Investigational Site Number 250001 | |
Villejuif, France, 94805 | |
Netherlands | |
Investigational Site Number 528001 | |
Amsterdam, Netherlands, 1066 CX | |
Investigational Site Number 528003 | |
Rotterdam, Netherlands, 3075 EA | |
Investigational Site Number 528002 | |
Utrecht, Netherlands, 3584 CX |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01636479 |
Other Study ID Numbers: |
TED12318 2012-000733-39 U1111-1127-2911 ( Other Identifier: UTN ) |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | May 17, 2018 |
Last Verified: | May 2018 |
Neoplasms |