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An open-label study...
An open-label study to investigate the cardiac safety profile of cabazitaxel in patients with advanced solid tumors
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- Maison-Blanche, Pierre (author)
- Hop Bichat Claude Bernard, Assistance Publ Hop Paris, Cardiol Unit, F-75877 Paris, France.
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- Dakhil, Shaker (author)
- Canc Ctr Kansas, Wichita, KS USA.
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- Baron, Ari (author)
- Calif Pacific Med Ctr, San Francisco, CA USA.
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- Rottey, Sylvie (author)
- Ghent Univ Hosp, Ghent, Belgium.
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- Millard, Fred (author)
- Moores UCSD Canc Ctr, La Jolla, CA USA.
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- Daugaard, Gedske (author)
- Rigshosp, DK-2100 Copenhagen, Denmark.
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- Machiels, Jean-Pascal (author)
- Catholic Univ Louvain, Clin Univ St Luc, Dept Med Oncol, B-1200 Brussels, Belgium.;Catholic Univ Louvain, Inst Rech Clin & Expt Pole MIRO, B-1200 Brussels, Belgium.
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- Conkright, William (author)
- Purchase Canc Grp, Paducah, KY USA.
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- Sharma, Sunil (author)
- Huntsman Canc Inst, Salt Lake City, UT USA.
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- Soetekouw, Patricia M. M. B. (author)
- Maastricht Univ Med Ctr, Div Med Oncol, Maastricht, Netherlands.
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- Yachnin, Jeffrey (author)
- Univ Uppsala Hosp, Uppsala, Sweden.
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- Sengelov, Lisa (author)
- Herlev Hosp, Dept Oncol, DK-2730 Herlev, Denmark.
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- Van Veldhuizen, Peter (author)
- Kansas City Vet Adm Med Ctr, Kansas City, MO USA.
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- Agarwala, Sanjiv S. (author)
- St Lukes Canc Ctr, Bethlehem, PA USA.;Temple Univ, Bethlehem, PA USA.
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- Semiond, Dorothee (author)
- Sanofi, Paris, France.
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- Chadjaa, Mustapha (author)
- Sanofi, Paris, France.
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- Shen, Liji (author)
- Sanofi Rech, Bridgewater, NJ USA.
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- Wade, James L. (author)
- Decatur Mem Hosp, Decatur, IL USA.
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Hop Bichat Claude Bernard, Assistance Publ Hop Paris, Cardiol Unit, F-75877 Paris, France Canc Ctr Kansas, Wichita, KS USA. (creator_code:org_t)
- 2014-04-10
- 2014
- English.
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In: Cancer Chemotherapy and Pharmacology. - : Springer Science and Business Media LLC. - 0344-5704 .- 1432-0843. ; 73:6, s. 1241-1252
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- This study assessed the cardiovascular safety of cabazitaxel, based on thorough evaluation of QT and non-QT variables, and the relationship between pharmacokinetic and pharmacodynamic electrocardiographic (ECG) profiles and the occurrence of Grade a parts per thousand yen3 cardiovascular adverse events. Patients with advanced solid tumors were treated with cabazitaxel 25 mg/m(2) every 3 weeks. Digital ECG recordings were obtained during Cycle 1 over 24 h after dosing. The primary end point was effect of cabazitaxel on QT interval corrected by the Fridericia formula (QTcF). Secondary end points were additional ECG parameters (QT, PR and QRS intervals, and heart rate), plasma pharmacokinetics of cabazitaxel and overall clinical safety. The pharmacodynamic (ECG) population included 94 patients. In 63 patients with a full 24-h ECG evaluation, the maximum upper bound of 90 % confidence interval (CI) for mean QTcF change from baseline was 7.46 ms (mean 4.8 ms), occurring at 1 h 30 min post-infusion. The slope of QTcF change from baseline versus cabazitaxel concentration was slightly negative (-0.012 [95 % CI -0.017; -0.008], equivalent to a 1.2 ms decrease per 100 ng/mL increase in cabazitaxel concentration). For non-QT variables, no effect was noted. No Grade a parts per thousand yen3 cardiac adverse events were observed; Grade a parts per thousand yen3 hypotension and lymphocele occurred in two patients and one patient, respectively. These results suggest that cabazitaxel has no clinically significant cardiovascular adverse effects in patients with advanced solid tumors.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Cabazitaxel
- QTc interval
- Cardiac safety
- Advanced solid tumors
- Pharmacokinetics
- ECG
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Maison-Blanche, ...
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Dakhil, Shaker
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Baron, Ari
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Rottey, Sylvie
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Millard, Fred
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Daugaard, Gedske
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Machiels, Jean-P ...
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Conkright, Willi ...
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Sharma, Sunil
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Soetekouw, Patri ...
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Yachnin, Jeffrey
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Sengelov, Lisa
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Van Veldhuizen, ...
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Agarwala, Sanjiv ...
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Semiond, Dorothe ...
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Chadjaa, Mustaph ...
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Shen, Liji
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Wade, James L.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Cancer Chemother ...
- By the university
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Uppsala University