A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy
NCT ID: NCT01685255
Last Updated: 2019-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
83 participants
INTERVENTIONAL
2012-08-31
2014-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epacadostat
Subjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.
Epacadostat
Tamoxifen
Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.
tamoxifen
Interventions
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Epacadostat
tamoxifen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who received maintenance paclitaxel or, bevacizumab, or alternative maintenance therapy (e.g. vaccines) are eligible for enrollment provided they have discontinued therapy at least 4 weeks for prior taxane and, at least 8 weeks for bevacizumab, or received medical monitor approval for time lapse from alternative maintenance therapy prior to randomization and recovered from toxicities to less than Grade 2.
* Subject must be currently in remission by clinical and radiological criteria (Response Evaluation Criteria for Solid Tumors \[RECIST 1.1\]).
a. If a PET scan or high-resolution CT scan is performed and demonstrates new disease \</= 1 cm, these subjects would be eligible.
* Clinical remission is defined as: asymptomatic and a negative physical examination.
* Scans are required post completion of platinum-containing therapy to document disease remission.
* Prior to the first-line regimen, CA 125 must have been elevated at first diagnosis, must have normalized with the first-line therapy/regimen, and is currently elevated:
a. CA 125 elevation is defined as 2 consecutive measurements that are both above the Upper Limit of Normal (ULN) at least 42 weeks apart, with the second measure showing further increases from the first measurement
1. If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.
2. CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at least 1 week apart (UK ONLY REQUIREMENT).
* CA 125 elevation must be at least 3 months from completion of first-line platinum-containing regimen.
* Documentation of at least 1 normal CA 125 level at approximately 3 months during or following first line therapy is required.
* Subjects must have available archived tumor tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate renal, hepatic, and bone marrow function based on screening laboratory assessments.
Exclusion Criteria
* Any other prior antitumor systemic therapy except for first-line chemotherapy associated with previous CA 125 normalization or maintenance paclitaxel, bevacizumab, or alternative maintenance therapy as approved by the medical monitor.
* Subjects with prior radiotherapy within 3 months of randomization and have not recovered from all radiotherapy-related toxicities, who have received radiation therapy to the chest within 3 months of randomization, or who have a history or radiation pneumonitis.
* Subjects with protocol-specified active autoimmune processes except vitiligo or thyroiditis.
* Subjects receiving investigational study drug for any indication, immunological-based treatment for any reason (except completed adjuvant therapy with medical monitor approval), or potent CYP3A4 inducers or inhibitors.
* Subjects receiving monoamine oxidase inhibitors (MAOIs) within the 21 days prior to screening; subjects who have ever had Serotonin Syndrome (SS) after receiving 1 or more serotonergic drugs.
* Subjects for whom tamoxifen therapy is contraindicated.
18 Years
FEMALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lance Leopold, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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La Jolla, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Evanston, Illinois, United States
Joliet, Illinois, United States
Iowa City, Iowa, United States
Covington, Louisiana, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Bridgewater, New York, United States
Buffalo, New York, United States
Mineola, New York, United States
Durham, North Carolina, United States
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Greenville, South Carolina, United States
Bendigo, , Australia
Heidelberg, , Australia
Herston, , Australia
Milton, , Australia
Randwick, , Australia
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Izhevsk, , Russia
Krasnodar, , Russia
Kursk, , Russia
Moscow, , Russia
Orenburg, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Yekaterinburg, , Russia
Chernivtsi, , Ukraine
Dnipro, , Ukraine
Kharkiv, , Ukraine
Lutsk, , Ukraine
Bebington, , United Kingdom
Cardiff, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Keighley, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
West Midlands, , United Kingdom
Countries
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References
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Kristeleit R, Davidenko I, Shirinkin V, El-Khouly F, Bondarenko I, Goodheart MJ, Gorbunova V, Penning CA, Shi JG, Liu X, Newton RC, Zhao Y, Maleski J, Leopold L, Schilder RJ. A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer. Gynecol Oncol. 2017 Sep;146(3):484-490. doi: 10.1016/j.ygyno.2017.07.005. Epub 2017 Jul 8.
Other Identifiers
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INCB 24360-210
Identifier Type: -
Identifier Source: org_study_id
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