A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• azenosertib — DRUG
  Azenosertib (ZN-c3) will be administered orally.

Study Details

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.

Key Dates

Start date

Feb 17, 2022

Status verified

Dec 2025

Primary completion

Dec 1, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

310 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1a/1b (Completed Enrollment)
  Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.
• Experimental: Part 2a: Arm 1 (Completed Enrollment)
  Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
• Experimental: Part 2a: Arm 2 (Completed Enrollment)
  Azenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule
• Experimental: Part 2b
  Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
• Experimental: Part 2c
  Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule

Primary Outcome Measure

Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2] [ Time Frame: Up to approximately 12 months from the enrollment of the last subject ]

Central Contacts

• Project Director
  858.263.4333
  [email protected]

Locations (44)

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