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COMPLETED Phase 1

Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

NCT01836705 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 60 participants
Start Date 2013-05
Est. Completion 2014-05
Phase Phase 1

Sponsor

Bristol-Myers Squibb

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01836705

The ClinicalTrials.gov registry entry for NCT01836705 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01836705 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Texas, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01836705?

The interventions under investigation include: SAR302503 (TG101348) (DRUG), Placebo SAR302503 (DRUG), Panolosetron (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01836705?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial