Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Public ClinicalTrials.gov record NCT01836705. 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
Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: \- To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors. Secondary Objectives: * To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo. * To assess the clinical and laboratory safety of SAR302503 * To document the plasma concentrations of SAR302503 at the time of ECG investigation. * To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503 concentration and QTcF * To explore antitumor activity
Study identification
- NCT ID
- NCT01836705
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 60 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
- Apr 30, 2013
- Primary completion
- Oct 31, 2013
- Completion
- Apr 30, 2014
- Last update posted
- Mar 4, 2025
2013 – 2014
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840003 | Los Angeles | California | 90048 | — |
| Investigational Site Number 840007 | Augusta | Georgia | 30912 | — |
| Investigational Site Number 840002 | Detroit | Michigan | 48201 | — |
| Investigational Site Number 840001 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840004 | Cincinnati | Ohio | 45267-0542 | — |
| Investigational Site Number 840005 | Philadelphia | Pennsylvania | 19111 | — |
| Investigational Site Number 840006 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840008 | San Antonio | Texas | 78229 | — |
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 2 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01836705, 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 Mar 4, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01836705 live on ClinicalTrials.gov.