A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

NCT ID: NCT05198804

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2025-05-31

Brief Summary

This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer.

Detailed Description

This is a Phase 1/2 open-label, multicenter study to evaluate the safety, clinical activity, PK, and PD of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer who have failed Poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance treatment.

Conditions

Ovarian Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZN-c3 and Niraparib

ZN-c3 in combination with Niraparib

Group Type: EXPERIMENTAL

ZN-c3

Intervention Type: DRUG

ZN-c3 will be administered.

Niraparib

Intervention Type: DRUG

Niraparib will be administered.

ZN-c3

ZN-c3 Monotherapy

Group Type: EXPERIMENTAL

ZN-c3

Intervention Type: DRUG

ZN-c3 will be administered.

Interventions

ZN-c3

ZN-c3 will be administered.

Intervention Type: DRUG

Niraparib

Niraparib will be administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.

2. Subjects must have platinum-resistant disease.

3. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.

4. Adequate hematologic and organ function.

5. Ability and willingness to take oral medication.

6. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.

Exclusion Criteria

1. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C).

2. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.

3. Any investigational drug therapy <28 days.

4. Prior treatment with a WEE1 inhibitor.

5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.

6. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

7. Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg).

8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV).

9. Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.

10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.

11. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).

12. Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges François Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

Arizona Oncology Associates (Wilmot HOPE) - USOR

Tucson, Arizona, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Colorado

Aurora, Colorado, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Spectrum Health System

Grand Rapids, Michigan, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Optimum Clinical Research Group- Women's Oncology

Albuquerque, New Mexico, United States

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Centre Hospitalier Lyon Sud

Saint-Genis-Laval, , France

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, , France

EDOG - Institut Claudius Regaud

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Countries

United States; France

Other Identifiers

GOG-3067

Identifier Type: OTHER

Identifier Source: secondary_id

2021-004161-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZN-c3-006

Identifier Type: -

Identifier Source: org_study_id