A RANDOMIZED, OPEN-LABEL, PHASE 2 STUDY OF THE IDO INHIBITOR INCB024360 VERSUS TAMOXIFEN FOR SUBJECTS WITH BIOCHEMICAL-RECURRENT-ONLY EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL CARCINOMA, OR FALLOPIAN TUBE CANCER FOLLOWING COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY
- Subjects who have received first-line chemotherapy, which must have been a
- Subjects who received maintenance paclitaxel or bevacizumab are eligible for
enrollment provided they have discontinued therapy at least (4 weeks for prior taxane
and at least 8 weeks for bevacizumab) 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]).
- Clinical remission is defined as: asymptomatic and a negative physical examination.
- Scans are required post completion of platinum-containing therapy to document disease
- 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:
- CA 125 elevation is defined as 2 consecutive measurements that are both above the ULN
at least 4 weeks apart, with the second measure showing further increases from the
- CA 125 elevation must be at least 6 months from completion of first-line
platinum-containing regimen and have not occurred while receiving maintenance
- Documentation of at least 1 normal CA 125 level at approximately 6 months (± 4 weeks)
or greater after completion of 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
- Subjects with any evidence of disease including new ascites as confirmed by imaging.
- Any other prior antitumor systemic therapy except for first-line chemotherapy
associated with previous CA 125 normalization.
- 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
- Subjects with protocol-specified active autoimmune processes except vitiligo or
- Subjects receiving investigational study drug for any indication, immunological-based
treatment for any reason, 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.