Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovar… (NCT02042430) | Clinical Trial Compass
CompletedEarly Phase 1
Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
United States17 participantsStarted 2014-08-25
Plain-language summary
This pilot Early Phase I clinical trial studies epacadostat before surgery in treating patients with newly diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range19 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:
* Newly diagnosed stage III or IV epithelial ovarian, fallopian or primary peritoneal carcinoma with or without ascites and potentially resectable disease agreeing to debulking surgery as standard therapy
* Pre-surgery tumor deemed amenable to core biopsy (with at least 100 mm\^3 tumor volume per biopsy)
* Patients must be willing and able to undergo ascites fluid collection pre- and post-study treatment if adequate ascites is present; patients without adequate ascites may also participate in the trial
* Patients must be willing and able to undergo a pre-surgery biopsy and wait 2 weeks before their debulking surgery; NOTE: consented patients with subsequent inadequate biopsy material will not receive INCB024360 or be analyzed and will be replaced; the study will be stopped if adequate tissue is not obtained in more than 2/3 of paired samples with a maximum accrual of 18 patients
* Women of all races and ethnic groups are eligible for this trial
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \> 70%)
* Any human leukocyte antigen (HLA) type
* Life expectancy of at least 6 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \> 11g/dL
* Total bilirubin \< 1.5 x institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) up…
What they're measuring
1
Number of participants with an increase in CD8+ T cells