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Phase 1 Safety Testing of SAR405838
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01636479
First received: July 2, 2012
Last updated: August 10, 2017
Last verified: August 2017
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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: | 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 |
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 ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 82 |
| Actual Study Start Date: | July 13, 2012 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | February 2019 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479
Locations
| 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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01636479 History of Changes |
| Other Study ID Numbers: |
TED12318 2012-000733-39 U1111-1127-2911 ( Other Identifier: UTN ) |
| Study First Received: | July 2, 2012 |
| Last Updated: | August 10, 2017 |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on August 17, 2017