epithelial ovarian, fallopian tube, and primary peritoneal cancer epithelial ovarian, fallopian tube, and primary peritoneal cancer
Conditions
Interventions
As part of prescreening, pretreatment biopsies (archival [= 5 years] or fresh biopsy tissue) will be collected and analyzed at the central testing laboratory (CTL), using central IHC assay (Cyclin E1
Sponsors
Incyte Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria include: • Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. • FFPE tumor tissue blocks or cut unstained tumor slides • Tumor sample obtained from fresh biopsy or resection or archival (stored = 5 years) FFPE block or slides
Exclusion criteria
Exclusion criteria: Exclusion criteria include: • Cytology samples, including fine needle aspirate specimens • Decalcified tissues • Bone samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint of the clinical performance study is to determine the clinical utility of the Cyclin E1 IHC 2460 pharmDx (Dako Omnis) as a CDx device for use of INCB123667 in patients with platinum resistant ovarian cancer, as supported by the relevant endpoints from the INCB123667-305 clinical study listed in Table 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints of the clinical performance study are reflective of the corresponding endpoints of INCB123667-305. The key secondary endpoint of the clinical performance study is: - Objective response by BICR (Blinded independent central review), defined as having a best overall response of CR (Complete response ) or PR (Partial response ), as determined by BICR per RECIST v1.1. Other secondary enpoints are: - DOR (duration of response) by BICR, defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by BICR per RECIST v1.1, or death due to any cause, whichever occurs first. - PFS (Progression-free survival) by investigator, defined as the time from the date of randomization until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. - Objective response by investigator, defined as having a best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1. - DOR by investigator, defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. - AEs, assessed by physical examinations, evaluating changes in vital signs and ECGs, and through clinical laboratory blood sample evaluations. - Treatment interruptions, dose reductions, and discontinuation of study treatment due to AEs. - HRQoL, assessed by changes from baseline in EORTC QLQ-C30, EORTC QLQ-OV28, and EQ-5D-5L questionnaire scores In addition to the CDx clinical utility objectives, the clinical performance study will evaluate the assay performance in the clinical setting through its diagnostic range and clinical staining performance for all samples that adhere to sample collection and handling requirements. Diagnostic range of G | — |
Countries
Australia, Belgium, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactA. Buffet
Incyte Corporation
Outcome results
None listed