BIOCHEMICAL-RECURRENT-ONLY EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL CARCINOMA, OR FALLOPIAN TUBE CANCER FOLLOWING COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY
Conditions
Interventions
Product Code: INCB024360
Pharmaceutical Form: Tablet
Current Sponsor code: INCB024360
Other descriptive name: (Z)-N-(3-Bromo-4-fluorophenyl)-N'-hydroxy-
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion 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 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 postcompletion 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: ? CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at least 1 week apart. ? CA 125 elevation must be at least 6 months from completion of first-line platinum-containing regimen and have not occurred while receiving maintenance therapy. ? 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 assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1.Subjects who are currently breastfeeding. 2.Subjects who have received any other prior antitumor therapy except for the first-line platinum-containing regimen with or without maintenance paclitaxel or bevacizumab. 3.Subjects with any unresolved toxicity greater than or equal to Grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity. 4.Subjects who have had 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 of radiation pneumonitis. 5.Subjects with prior malignancies other than EOC, PPC, or FTC for which the subject has not been disease free for 3 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix. 6.History of hepatitis or positive serology as follows: a.Hepatitis B (HepB) screening testing required: HepB SAg (hepatitis B surface antigen); Anti-HepB SAg (antibody against hepatitis B surface antigen); Anti-Hepatitis B core IgG (antibody against hepatitis B core antigen). Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive anti-HepB SAg test as the only evidence of prior exposure may participate in the trial. b.Hepatitis C screening testing required: HCV-antibody (antibody against hepatitis C virus); HCV-RNA (serum test for circulating virus, based on detecting RNA) 7.Subjects known to be HIV-positive. 8.Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving therapy for an autoimmune or inflammatory disease. a.Subjects with vitiligo, thyroiditis or eczema, but otherwise not meeting criterion 12 may be enrolled. Individual cases can be discussed with the sponsor. 9.Subjects who are currently receiving therapy with a potent CYP3A4 inducer or inhibitor (Appendix C). Subjects may enter screening when therapy with the potent inhibitor or inducer is completed. 10.Use of any UGT1A9 inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period. 11.Subjects for who tamoxifen is contraindicated. 12.Subjects who are receiving any immunologically-based treatment for any reason, including chronic use of systemic steroid at doses = 7.5 mg/day prednisone equivalents; use of inhaled or topical steroids is acceptable. 13.Subjects who have undergone an organ transplant(s) including allogeneic stem cell or bone marrow transplants. 14.Subjects being treated with a MAOI, or drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within 3 weeks prior to screening. See Appendix D for prohibited medications associated with MAO inhibition. 15.Subjects who have had prior SS (Boyer and Shannon 2005). 16.Subjects who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy based on PFS of INCB024360 versus tamoxifen among subjects with CA-125 elevation following complete remission with first-line chemotherapy for advanced disease by investigator.; Secondary Objective: To evaluate the CA-125 response rate (GCIG criteria). To evaluate OS. To determine efficacy based on PFS by independent central review. To determine the safety and tolerability of INCB024360 in this population. ; Primary end point(s): Progression-free survival, using RECIST 1.1 definition of objective progression as determined by the investigator. ;Timepoint(s) of evaluation of this end point: The evaluation of tumor lesions will be every 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CA-125 response rate, using GCIG criteria Duration of OS. Progression-free survival using RECIST 1.1 definition of objective progression as determined by independent central review. Evaluate safety and tolerability of INCB024360. ;Timepoint(s) of evaluation of this end point: The treatment cycles of 28 days are defined and patients will be assessed at the start of each cycle. | — |
Countries
Canada, United Kingdom, United States
Contacts
Public ContactIncyte Corporation Call Centre
Incyte Corporation
Outcome results
None listed