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

Stopped early · Phase 2

Conditions studied: Ovarian Cancer, Genitourinary (GU) Tumors

In brief

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.

Key facts

Study ID

NCT01685255

Run by

Incyte Corporation

People needed

83

Starts

2012-08-01

Expected to finish

2014-10-23

Last updated by the study team

2019-03-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Evanston, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Covington, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Bridgewater, New York, United States
• Study site — Buffalo, New York, United States
• Study site — Mineola, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Abington, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Bendigo, Australia
• Study site — Heidelberg, Australia
• Study site — Herston, Australia
• Study site — Milton, Australia
• Study site — Randwick, Australia
• Study site — Calgary, Alberta, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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