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INCB123667

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.

Table of contents

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.[1][2] Both studies are interventional, which means participants receive a planned treatment and outcomes are measured over time.[1][2]

Phase 2 study: monotherapy in platinum-resistant ovarian cancer

NCT07023627 is a Phase 2 study with 160 participants.[1] 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.[1] Monotherapy means the study drug is given alone, not with another cancer medicine.[1]

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.[1] IRC means an independent review group that checks the scans and results in a standard way.[1]

Phase 3 study: comparison with chemotherapy

NCT07214779 is a Phase 3 study with 466 participants.[2] It compares INCB123667 with the investigator’s choice of chemotherapy in participants with platinum-resistant ovarian cancer and cyclin E1 overexpression.[2] The chemotherapy options listed in the trial are paclitaxel, topotecan hydrochloride, gemcitabine hydrochloride, and Caelyx pegylated liposomal.[2]

This phase is meant to compare the study treatment with standard treatment choices in a larger group of people.[2] The trial is authorised, which means it has been approved to start or continue according to the source data.[2]

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.[1] This tells researchers whether the tumors shrink enough to count as a response.[1]

The Phase 3 study measures progression-free survival and overall survival.[2] 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.[2] The Phase 3 study uses BICR for progression-free survival, which means a blinded independent central review of the scans or disease status.[2]

Who the trials are for

Both trials are for people with ovarian cancer that is platinum-resistant and shows cyclin E1 overexpression.[1][2] The source data do not list more detailed eligibility rules, such as age limits, prior treatments, or lab test requirements.[1][2]

Because the trials focus on a specific tumor feature, not every person with ovarian cancer would qualify.[1][2] The cancer feature used for selection is cyclin E1 overexpression, which is a biomarker, meaning a measurable sign in the tumor.[1][2]

Key terms explained

Authorised means the study has been approved in the source record.[1][2] Interventional means the trial gives a treatment and then measures what happens.[1][2] RECIST v1.1 is a standard system used to judge tumor response on scans.[1][2]

Randomization means participants are assigned to a treatment group by chance.[2] Progression means the cancer is getting worse.[2] Overall survival measures how long participants live after entering the study.[2]

Trial ID Phase Condition studied Status Enrollment
NCT07023627 Phase 2 Platinum-resistant ovarian cancer with cyclin E1 overexpression Authorised 160
NCT07214779 Phase 3 Platinum-resistant ovarian cancer with cyclin E1 overexpression Authorised 466

FAQ

  • What condition is being studied in these trials? The trials are studying platinum-resistant ovarian cancer, also called PROC. They focus on participants whose tumors show cyclin E1 overexpression.
  • Who can take part in these studies? The target population is people with platinum-resistant ovarian cancer and cyclin E1 overexpression. The trial data do not give more detailed entry rules.
  • What phases are the trials in? There is one Phase 2 study and one Phase 3 study. Phase 2 looks mainly at whether the treatment works, while Phase 3 compares it with chemotherapy in a larger group.
  • What is being measured in the trials? The Phase 2 study measures objective response, meaning complete response or partial response confirmed by review. The Phase 3 study measures progression-free survival and overall survival.
  • What treatments are being compared? One study looks at 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 as monotherapy. The Phase 3 study compares it with investigator's choice of chemotherapy, which includes paclitaxel, topotecan hydrochloride, gemcitabine hydrochloride, or Caelyx pegylated liposomal.

Ongoing Clinical Trials on INCB123667

  • A Study of INCB123667 in Patients With Platinum-Resistant Ovarian Cancer That Has High Levels of Cyclin E1 Protein

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Spain

  • Phase 3 Study of INCB123667 versus investigator’s choice of chemotherapy drug combination in patients with platinum‑resistant ovarian cancer and cyclin E1 overexpression

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +2

Glossary

  • Platinum-resistant ovarian cancer (PROC): Ovarian cancer that does not respond well to platinum-based treatment or comes back soon after it.
  • Cyclin E1 overexpression: A tumor feature meaning the cancer cells have too much cyclin E1. In these trials, it is used to select who may join.
  • Phase 2: A study stage that mainly looks at early signs of how well a treatment works and continues safety checks.
  • Phase 3: A larger study stage that compares a treatment with standard care or another treatment to see which works better.
  • Monotherapy: Treatment with one study drug only, without combining it with other anti-cancer medicines.
  • Randomization: A process where participants are assigned to a treatment group by chance.
  • Objective response: A measured tumor shrinkage result, including complete response or partial response.
  • Complete response (CR): No visible sign of cancer on scans or exams used in the study.
  • Partial response (PR): The cancer has shrunk, but it has not disappeared completely.
  • Progression-free survival (PFS): The length of time after randomization before the cancer gets worse or the participant dies.
  • Overall survival (OS): The length of time after randomization until death from any cause.
  • RECIST v1.1: A standard way to measure whether tumors get smaller, stay stable, or grow.