Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

Completed · Phase 1 · Has a placebo group

Conditions studied: Neoplasm Malignant

In brief

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

Key facts

Study ID: NCT01836705
Run by: Bristol-Myers Squibb
People needed: 60
Starts: 2013-05-01
Expected to finish: 2014-05-01
Last updated by the study team: 2025-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist

You may not qualify if…

Prior history of torsades de pointe, or congenital long QT syndrome.
Conditions with screening ECG in which repolarization is difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: High degree atrioventricular (AV) block, pacemaker, atrial fibrillation or flutter
Screening ECG with QTc B or QTc F ≥480 msec (within 8 days of Day-1)
Significant hypokalemia at screening (K+ <3.5 mmol/L) (within 8 days of Day-1)
Significant hypomagnesemia at screening and inclusion (Mg++ <0.7 mmol/L) (within 8 days of Day -1)
Patient receives (and cannot discontinue), or is scheduled to receive, a concomitant treatment known to carry a risk of both QT prolongation and torsade de pointe for 2 weeks before Day 1 and for the duration of Segment 1
Absence of completion of all prior chemotherapy, biological therapy, hormonal therapy, targeted non-cytotoxic therapy ≥3 weeks; and radiotherapy ≥2 weeks prior to inclusion.
Patients with uncontrolled brain metastases or primary brain tumor. Patients with brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for ≥ 2 weeks.
Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase.
Anticipation of need for a major surgical procedure or radiation therapy during the study treatment.
Concurrent treatment in another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, hormonal therapy, radiotherapy, chemoembolization, cryotherapy, targeted non-cytotoxic therapy or patients planning to receive these treatments during the study.
Inadequate organ function as defined by:
Absolute neutrophil count (ANC) <1.5 X 10\^9/L
Platelet count <100 X 10\^9/L
Hemoglobin: <9 g/dL
Serum creatinine >1.5 x the upper limit of normal (ULN)
Serum amylase or lipase >1.5 x ULN
Total bilirubin >1.5 x ULN
Aspartate aminotransferase or alanine aminotransferase ≥2.5 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2 at study entry.
Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
Ongoing or recent history (within 3 months of Day 1 Segment 1) of clinically significant dysrrhythmia.
Patients taking a beta blocker within 7 days to Day 1 Segment 1 and during Segment 1
Other concurrent serious illness or medical condition, including active infection or HIV disease.
Patients with known active (acute or chronic) Hepatitis A, B, C, and hepatitis B and or C carriers. Prior history of chronic liver disease.

Where it is running

Investigational Site Number 840003 — Los Angeles, California, United States
Investigational Site Number 840007 — Augusta, Georgia, United States
Investigational Site Number 840002 — Detroit, Michigan, United States
Investigational Site Number 840001 — St Louis, Missouri, United States
Investigational Site Number 840004 — Cincinnati, Ohio, United States
Investigational Site Number 840005 — Philadelphia, Pennsylvania, United States
Investigational Site Number 840006 — San Antonio, Texas, United States
Investigational Site Number 840008 — San Antonio, Texas, United States
Investigational Site Number 056001 — Brussels, Belgium
Investigational Site Number 056002 — Ghent, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.