Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophor… (NCT03382574) | Clinical Trial Compass
TerminatedEarly Phase 1
Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy
Stopped: it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down.
United States, Israel2 participantsStarted 2019-03-14
Plain-language summary
This randomized pilot early phase I trial studies how well denosumab works in BRCA1/2 mutations carriers scheduled for risk-reducing salpingo-oophorectomy. Denosumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be premenopausal (defined as \< 3 months since last menstrual period OR serum follicle-stimulating hormone \[FSH\] \< 20 mIU/mL)
* Documented germline pathogenic or likely pathogenic variant in the BRCA1 or BRCA2 genes
* Participants must be scheduled for or in the process of scheduling a risk-reducing salpingo-oophorectomy with or without hysterectomy - either bilateral or unilateral (if prior unilateral oophorectomy or salpingectomy for benign condition)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Leukocytes \>= 3,000/microliter
* Absolute neutrophil count \>= 1,500/microliter
* Platelets \>= 100,000/microliter
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\])) =\< 1.5 x institutional ULN
* Creatinine clearance \>= 30 mL/min
* Serum calcium or albumin adjusted \>= 8.0 mg/dL and =\< 11.5 mg/dL
* Participant must have a negative urine or serum pregnancy test 14 days prior to randomization or drug administration; the effects of denosumab on the developing human fetus at the recommended therapeutic dose may cause fetal harm when administered to pregnant women; women of childbearing potential must agree to use adequate contraception from time of drug administration to time of surgery; should a woman become pregn…
What they're measuring
1
Ki67 Proliferation Index Fallopian Tube Fimbrial Epithelial Cells