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NCT01836705 · ClinicalTrials.gov registry record · Phase 1
Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
A Phase 1 study of Neoplasm Malignant, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 10
- Study locations
NCT01836705: Completed Phase 1 study of Neoplasm Malignant, sponsored by Bristol-Myers Squibb.
NCT01836705 is a Phase 1 study of Neoplasm Malignant that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 60 participants, below the 283-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (79% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01836705, a Phase 1 study of Neoplasm Malignant, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 10
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG SAR302503 (TG101348)
- DRUG Placebo SAR302503
- DRUG Panolosetron
Study Locations (10)
Texas
- Investigational Site Number 840006 - San Antonio
- Investigational Site Number 840008 - San Antonio
Other
- Investigational Site Number 056001 - Brussels
- Investigational Site Number 056002 - Ghent
California
- Investigational Site Number 840003 - Los Angeles
Georgia
- Investigational Site Number 840007 - Augusta
Michigan
- Investigational Site Number 840002 - Detroit
Missouri
- Investigational Site Number 840001 - St Louis
Ohio
- Investigational Site Number 840004 - Cincinnati
Pennsylvania
- Investigational Site Number 840005 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01836705 record still lists
NCT01836705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 283-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Neoplasm Malignant appearing as the primary indexed condition, and to 3 interventions - of which SAR302503 (TG101348) is the first listed.
NCT01836705 lists 10 locations in 8 states (Texas, Other, California).
Frequently Asked Questions
What is clinical trial NCT01836705 about?
NCT01836705 is a clinical study titled "Effect of SAR302503 on ECG Activity in Patients With Solid Tumors". 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 ra...
What is the current status of trial NCT01836705?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2013-05. Estimated completion is 2014-05.
What conditions does trial NCT01836705 study?
This clinical trial studies the following conditions: Neoplasm Malignant.
What interventions are being tested in trial NCT01836705?
The interventions under investigation include: SAR302503 (TG101348) (DRUG), Placebo SAR302503 (DRUG), Panolosetron (DRUG).
Who is sponsoring clinical trial NCT01836705?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01836705 being conducted?
This trial has 10 study locations across California, Georgia, Michigan, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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