In short
Clinical trials are studying 8-ETHOXY-N-((3R,4S)-3-METHYL-1-(METHYLSULFONYL)PIPERIDIN-4-YL)-7-(1H-PYRAZOL-4-YL)-[1,2,4]TRIAZOLO[1,5-A]PYRIDIN-2-AMINE in people with platinum-resistant ovarian cancer and cyclin E1 overexpression. These studies aim to assess how well it works and, in later research, how it compares with standard chemotherapy. The trials include adults with this specific type of ovarian cancer.
Key points
- Two authorised clinical trials are studying 8-ETHOXY-N-((3R,4S)-3-METHYL-1-(METHYLSULFONYL)PIPERIDIN-4-YL)-7-(1H-PYRAZOL-4-YL)-[1,2,4]TRIAZOLO[1,5-A]PYRIDIN-2-AMINE in platinum-resistant ovarian cancer with cyclin E1 overexpression. One Phase 2 study is looking at the drug as monotherapy and measuring objective response. One Phase 3 study is comparing it with investigator's choice of chemotherapy and measuring progression-free survival and overall survival. The target population in both trials is people with this specific ovarian cancer subtype. Enrollment is 160 in the Phase 2 study and 466 in the Phase 3 study. Together, these trials are focused on whether the treatment can help control disease better than current options.
Clinical trial overview
These trials are studying 8-ETHOXY-N-((3R,4S)-3-METHYL-1-(METHYLSULFONYL)PIPERIDIN-4-YL)-7-(1H-PYRAZOL-4-YL)-[1,2,4]TRIAZOLO[1,5-A]PYRIDIN-2-AMINE in people with platinum-resistant ovarian cancer and cyclin E1 overexpression. Both studies are interventional, which means participants receive a planned treatment and outcomes are measured over time.
Phase 2 study: monotherapy in platinum-resistant ovarian cancer
NCT07023627 is a Phase 2 study with 160 participants. It is designed to evaluate the efficacy of INCB123667 monotherapy in participants with platinum-resistant ovarian cancer and cyclin E1 overexpression, also called PROC with cyclin E1 overexpression. Monotherapy means the study drug is given alone, not with another cancer medicine.
The primary outcome is objective response by IRC, which means the study checks how many participants have a confirmed complete response or partial response based on RECIST v1.1 tumor rules. IRC means an independent review group that checks the scans and results in a standard way.
Phase 3 study: comparison with chemotherapy
NCT07214779 is a Phase 3 study with 466 participants. It compares INCB123667 with the investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer and cyclin E1 overexpression. The chemotherapy options listed in the trial are paclitaxel, topotecan hydrochloride, gemcitabine hydrochloride, and Caelyx pegylated liposomal.
This phase is meant to compare the study treatment with standard treatment choices in a larger group of people. The trial is authorised, which means it has been approved to start or continue according to the source data.
What the trials measure
The Phase 2 study measures objective response, defined as a confirmed complete response or partial response by IRC using RECIST v1.1. This tells researchers whether the tumors shrink enough to count as a response.
The Phase 3 study measures progression-free survival and overall survival. Progression-free survival is the time from randomization until the cancer gets worse or the participant dies, and overall survival is the time from randomization until death from any cause. The Phase 3 study uses BICR for progression-free survival, which means a blinded independent central review of the scans or disease status.
Who the trials are for
Both trials are for people with ovarian cancer that is platinum-resistant and shows cyclin E1 overexpression. The source data do not list more detailed eligibility rules, such as age limits, prior treatments, or lab test requirements.
Because the trials focus on a specific tumor feature, not every person with ovarian cancer would qualify. The cancer feature used for selection is cyclin E1 overexpression, which is a biomarker, meaning a measurable sign in the tumor.
Key terms explained
Authorised means the study has been approved in the source record. Interventional means the trial gives a treatment and then measures what happens. RECIST v1.1 is a standard system used to judge tumor response on scans.
Randomization means participants are assigned to a treatment group by chance. Progression means the cancer is getting worse. Overall survival measures how long participants live after entering the study.