Baseline heart rate-corrected QT and eligibility for clinical trials in oncology

Journal of Clinical Oncology

Volumn 21, Issue 17, 2003, Pages 3378-3379

  Varterasian, Mary ^a,b   Meyer, Mark ^a,b   Fingert, Howard ^a,b   Radlowski, Diane ^a,b   Asbury, Peggy ^a,b   Zhou, Xiaofeng ^a,b   Healey, Diane ^a,b  

^a PFIZER INC   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ADULT; AGED; CLINICAL TRIAL; ECHOCARDIOGRAPHY; FEMALE; HEART RATE; HUMAN; LETTER; MALE; MIDDLE AGED; NEOPLASM; PATIENT SELECTION; RETROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; ECHOCARDIOGRAPHY; FEMALE; HEART RATE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PATIENT SELECTION; RETROSPECTIVE STUDIES;

EID: 0141576728     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2003.99.104     Document Type: Letter

References (6)

1. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3956B1-02-FDA-Preliminary%20Concept.doc (draft FDA/ICH guidance, November 15, 2002)
2. Britten CD, Rowinsky EK, Soignet S, et al: A phase I and pharmacological study of the farnesyl protein transferase inhibitor L-778, 123 in patients with solid malignancies. Clin Cancer Res 7: 3894-3903, 2001
3. Goldberg RJ, Bengtson J, Chen A, et al: Duration of the QT interval and total and cardiovascular mortality in healthy persons (the Framingham Heart Study experience). Am J Cardiol 67: 55-58, 1991
4. Elming H, Holm E, Jun L, et al: The prognostic value of the QT interval and QT interval dispersion in all-cause and cardiac mortality and morbidity in a population of Danish citizens. Eur Heart J 19: 1391-1400, 1998
5. Trisenox New Drug Application No. 21-248, Section 6.2.4
6. Schwartz CL, Hobbie WL, Truesdell S, et al: Corrected QT interval prolongation in anthracycline-treated survivors of childhood cancer. J Clin Oncol 11: 1906-1910, 1993