Ovarian Cancer Clinical Trial
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
Summary
This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 (epacadostat) versus tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission with first-line chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Subjects who have received first-line chemotherapy, which must have been a platinum-containing regimen.
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
If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.
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:
Subjects with any evidence of new disease (> 1 cm) including new ascites as confirmed by imaging.
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.
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There is 1 Location for this study
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
Ekaterinburg , , Russian Federation
Izhevsk , , Russian Federation
Krasnodar , , Russian Federation
Kursk , , Russian Federation
Moscow , , Russian Federation
Orenburg , , Russian Federation
St. Petersburg , , Russian Federation
Ufa , , Russian Federation
Chernivtsi , , Ukraine
Dnepropetrovsk , , 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
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