Phase 1 Safety Testing of SAR405838
Public ClinicalTrials.gov record NCT01636479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01636479
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2012 (Type not available)
- Primary completion
- Mar 5, 2018 (Actual)
- Completion
- Mar 5, 2018 (Actual)
- Last update posted
- May 17, 2018
2012 – 2018
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840101 | Boston | Massachusetts | 02114 | — |
| Investigational Site Number 840001 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 840002 | New York | New York | 10021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01636479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2018 · Synced Oct 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01636479 live on ClinicalTrials.gov.