Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the EU / 2025-524641-27-00
Authorised, recruiting Phase III

A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

2025-524641-27-00 · tracked via the Priya Life Science EU tracker
Sponsor
K-Group Beta Inc
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
21/08/2026
Enrollment target
197
Sites
Germany, Spain, Italy, Belgium, Poland, France, Ireland

Condition studied

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Investigational medicinal product(s)

Azenosertib (also known as ZN-c3; KP-2638)GEMCITABINEAkynzeo 300 mg/0.5 mg hard capsulesTOPOTECANDOXORUBICINPACLITAXEL

Eligibility

Age group
18-64 years, 65+ years
Sex
Female

Primary endpoint

Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator

Endpoint detail

Key secondary endpoint: Overall Survival (OS), Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator, Key secondary endpoint: Change from baseline in the following: • Abdominal/gastrointestinal symptoms as measured by EORTC-QLQ-OV28 (Items 31 to 36) • Remaining PRO symptom scales as measured by EORTC-QLQ-OV28 (Items 37 to 49) • Global Health Status and QOL as measured by EORTC-QLQ-C30 (Items 29 and 30) and EQ-5D-5L VAS, Additional Secondary Endpoint: PFS, ORR, and Duration Of Response (DOR) as defined by RECIST v1.1 and as assessed by BICR • DOR as defined by RECIST v1.1 and as assessed by Investigator • CA-125 response as defined by GCIG criteria • PFS2, Additional Secondary Endpoint: TEAEs graded according to NCI-CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524641-27-00 on CTIS ↗ ← All trials in the EU