Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
3 other identifiers
interventional
60
2 countries
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 5, 2025
June 1, 2014
6 months
April 17, 2013
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
QTc Friderica (QTcF) parameter
16 days
Secondary Outcomes (9)
Electrocardiographic parameters (Heart Rate)
16 days
Electrocardiographic parameters (QT)
16 days
Electrocardiographic parameters (QTcBazett)
16 days
Electrocardiographic parameters (QTcN)
16 days
Electrocardiographic parameters (PR interval)
16 days
- +4 more secondary outcomes
Study Arms (1)
Single-sequence
EXPERIMENTALSAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days)
Interventions
Pharmaceutical form:solution Route of administration: intravenous
Eligibility Criteria
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)
- 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
- 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Investigational Site Number 840003
Los Angeles, California, 90048, United States
Investigational Site Number 840007
Augusta, Georgia, 30912, United States
Investigational Site Number 840002
Detroit, Michigan, 48201, United States
Investigational Site Number 840001
St Louis, Missouri, 63110, United States
Investigational Site Number 840004
Cincinnati, Ohio, 45267-0542, United States
Investigational Site Number 840005
Philadelphia, Pennsylvania, 19111, United States
Investigational Site Number 840006
San Antonio, Texas, 78229, United States
Investigational Site Number 840008
San Antonio, Texas, 78229, United States
Investigational Site Number 056001
Brussels, 1200, Belgium
Investigational Site Number 056002
Ghent, 9000, Belgium
Related Publications (1)
Ogasawara K, Xu C, Yin J, Darpo B, Carayannopoulos L, Xue H, Palmisano M, Krishna G. Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors. Clin Pharmacol Drug Dev. 2021 Apr;10(4):366-375. doi: 10.1002/cpdd.850. Epub 2020 Jul 16.
PMID: 32673446DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 22, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2013
Study Completion
May 1, 2014
Last Updated
March 5, 2025
Record last verified: 2014-06