Abstract

This was a multi-center, non-randomized, open-labeled, uncontrolled, Phase II study of Elinafide in ovarian cancer patients. Patients must have had histologically confirmed ovarian cancer and must have received fewer than four different chemotherapy regimens. The objectives of this study were primarily to determine the efficacy and safety of Elinafide as salvage therapy for patients with recurrent/persistent epithelial ovarian carcinoma. The secondary endpoint was to determine the objective response rate, time to progression, duration of response, and CA-125 levels after treatment with Elinafide. The Elinafide was given at the Clinical Research Center (CRC) for the first three courses. The Elinafide was given IV over 1 hour every week for three consecutive weeks, with a one week rest. Pharmacokinetic blood samples were obtained weekly before and after each treatment. Patients were examined every week for muscle weakness and a Quality of Life Questionnaire was performed before each new 4 week course. Tumor and cardiac evaluations were performed every 2 courses. Blood levels for Creatinine Kinase (CK) were obtained weekly to assess for the primary toxicity of muscle weakness. Laboratory values were obtained weekly to monitor for any other toxicities.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-40
Application #
6566908
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2002
Total Cost
Indirect Cost

  Institution

Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gibson, Kelly S; Stark, Sydney; Kumar, Deepak et al. (2017) The relationship between gestational age and the severity of neonatal abstinence syndrome. Addiction 112:711-716

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