December 7, 2019

The Department of Gynecology & Obstetrics has several ongoing clinical trials. They include:

• Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer, a phase I, open-label, non-randomized multicenter dose-escalation study within Johns Hopkins Ovarian Cancer SPORE, with the primary objective to determine the maximally tolerated dose (MTD) of fostamatinib when administered with weekly paclitaxel in women with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Goals for this trial are to identify the dose of fostamatinib to use in combination with paclitaxel for the treatment of ovarian cancer and to estimate the efficacy of this combination in a small cohort of women with ovarian cancer.
• Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer (CAPRI), a study within Johns Hopkins Ovarian Cancer SPORE evaluating the combination of olaparib and AZD6738 for the treatment of recurrent ovarian cancer. Goals for this research are to determine whether the combination of olaparib and AZD6738 is safe and tolerable for women with ovarian cancer and to determine the efficacy of the combination of olaparib and AZD6738 in women with ovarian cancer.
• Origins in Child Health and Resilience in Development (ORCHARD), a study to identify and assess multilevel risk factors for disease development (obesity, neurodevelopment disorders), including molecular, clinical and social risk factors during pregnancy and childhood. The research team hopes to be better able to explain the factors driving susceptibility to disease in the local community, leading to the discovery of preventive and therapeutic strategies to ameliorate the burden of chronic disease in children. Pregnant women who are 20 weeks and less may join this study. Participants have blood and urine draws, and oral and vaginal swabs collected. Several questionnaires are also completed. Participants receive up to $60 in compensation. Please contact ircfm@jhu.edu for more information. 
• Effects of Simavastin on Uterine Leiomyoma Size, a phase II double-blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility. The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add-on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires.