Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Pilot Study of the Immunological Effects of Neo-Adjuvant INCB024360 in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
8 other identifiers
interventional
17
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Aug 2014
Typical duration for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedStudy Start
First participant enrolled
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2016
CompletedDecember 13, 2024
December 1, 2024
2.3 years
January 20, 2014
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with an increase in CD8+ T cells
The correlation between results of the IDO expression levels analyzed by IHC and the Kyn/Trp ratios will be analyzed if available.
Baseline to day 15
Secondary Outcomes (10)
Change in number and character of tumor infiltrating lymphocytes
Baseline to up to day 35
Change in gene signatures as assessed by microarray analysis
Baseline to up to day 35
Change in character of the cellular content of PBMCs and ascites fluid, determined by multiparameter flow cytometry
Baseline to up to day 35
Change in fluid transcriptomes in PBMC and ascites
Baseline to up to day 35
Change in ongoing and nascent anti-tumor response antigens associated with ovarian cancer, including NY-ESO-1, PRAME and mesothelin
Baseline to up to day 35
- +5 more secondary outcomes
Study Arms (1)
Treatment (IDO1 inhibitor INCB024360)
EXPERIMENTALPatients receive IDO1 inhibitor INCB024360 PO BID on days 1-14 and undergo surgery on day 15. Treatment continues in the absence of disease progression or unacceptable toxicity. In circumstances where there are medical or administrative reasons for delaying surgery, treatment with IDO1 inhibitor INCB024360 may continue for up to 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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 to 2.5 times upper limit of normal (ULN)
- Creatinine \< 1.5 x institutional upper limit of normal OR creatinine clearance \> 60 ml/min OR \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- +4 more criteria
You may not qualify if:
- Patients who have had prior systemic therapy or radiotherapy for stage III or IV epithelial ovarian, fallopian or primary peritoneal carcinoma
- Extensive active brain disease including symptomatic brain metastases or presence of leptomeningeal disease
- Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs; any cyclooxygenase-2 (COX-2) inhibitors are permitted
- Use of any UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol (17-beta), flutamide, gefitinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin, and probenecid propofol, quinidine, ritonavir, sorafenib, sulfinpyrazone, valproic acid, and verapamil; patients must avoid UGT1A9 inhibitors from the screening period through active treatment with INCB024360 and for one week after discontinuation of INCB024360
- Uncontrolled intercurrent illness including, but not limited to:
- Unstable angina pectoris
- Cardiac arrhythmia
- Congestive heart failure
- Psychiatric illness/social situations that would limit compliance with study requirements
- Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves
- Pregnancy or nursing or unwilling to take adequate birth control during therapy; NOTE: breastfeeding should be discontinued
- Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder
- Patients who had, within the past 6 months, a cardiovascular accident (CVA) or at risk for arterial thrombus such as severe peripheral vascular disease (PVD) and carotid artery disease (CAD)
- History of autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; active or inactive auto-immune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, etc.) requiring treatment
- Vitiligo, thyroiditis or eczema requiring systemic steroids at a dose =\< 7.5 mg/day of prednisone or equivalent; individual cases can be discussed with the principal investigator
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunle Odunsi
Cancer Immunotherapy Trials Network
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2014
First Posted
January 22, 2014
Study Start
August 25, 2014
Primary Completion
November 29, 2016
Study Completion
November 29, 2016
Last Updated
December 13, 2024
Record last verified: 2024-12