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.

View Eligibility Criteria

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
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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT01685255

Recruitment Status:

Terminated

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT01685255

Recruitment Status:

Terminated

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider