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Trial record 1 of 1 for:    tes13519
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Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836705
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

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

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR302503 (TG101348) Drug: Placebo SAR302503 Drug: Panolosetron Phase 1

Detailed Description:
Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Single-sequence
SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days)
Drug: SAR302503 (TG101348)

Pharmaceutical form:capsule

Route of administration: oral


Drug: Placebo SAR302503

Pharmaceutical form:capsule

Route of administration: oral


Drug: Panolosetron

Pharmaceutical form:solution

Route of administration: intravenous

Other Name: Aloxi®




Primary Outcome Measures :
  1. QTc Friderica (QTcF) parameter [ Time Frame: 16 days ]

Secondary Outcome Measures :
  1. Electrocardiographic parameters (Heart Rate) [ Time Frame: 16 days ]
  2. Electrocardiographic parameters (QT) [ Time Frame: 16 days ]
  3. Electrocardiographic parameters (QTcBazett) [ Time Frame: 16 days ]
  4. Electrocardiographic parameters (QTcN) [ Time Frame: 16 days ]
  5. Electrocardiographic parameters (PR interval) [ Time Frame: 16 days ]
  6. Electrocardiographic parameters (QRS interval) [ Time Frame: 16 days ]
  7. Anti-tumor activity [ Time Frame: 16 or more days ]
  8. Number of participants with Adverse Events [ Time Frame: 16 or more days ]
  9. Pharmacokinetic parameter: Cmax, AUC0-24, Tmax, Tmax, Ctrough [ Time Frame: 16 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

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

Exclusion criteria:

  • 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.
  • Patients with history of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications.
  • Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
  • Contra-indications for palonosetron.
  • Use of drugs or herbal agents known to be at least moderate inhibitors or inducers of CYP3A4, sensitive CYP3A4 substrate, or CYP3A4 substrate with narrow therapeutic index, within 2 weeks of Day 1 and during study.
  • Concomitant treatment with H2-blockers is not allowed within 7 days prior to Day 1 Segment 1 and during entire study.
  • Known hypersensitivity to any excipients in IMP formulations.
  • Pregnant or lactating females
  • Women of childbearing potential, unless using effective contraception (other than oral contraceptives) while on study drug. Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836705


Locations
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United States, California
Investigational Site Number 840003
Los Angeles, California, United States, 90048
United States, Georgia
Investigational Site Number 840007
Augusta, Georgia, United States, 30912
United States, Michigan
Investigational Site Number 840002
Detroit, Michigan, United States, 48201
United States, Missouri
Investigational Site Number 840001
St Louis, Missouri, United States, 63110
United States, Ohio
Investigational Site Number 840004
Cincinnati, Ohio, United States, 45267-0542
United States, Pennsylvania
Investigational Site Number 840005
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Investigational Site Number 840006
San Antonio, Texas, United States, 78229
Investigational Site Number 840008
San Antonio, Texas, United States, 78229
Belgium
Investigational Site Number 056001
Bruxelles, Belgium, 1200
Investigational Site Number 056002
Gent, Belgium, 9000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01836705    
Other Study ID Numbers: TES13519
2012-005642-38 ( EudraCT Number )
U1111-1115-7323 ( Other Identifier: UTN )
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Neoplasms