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ZN-c3 + Niraparib for Ovarian Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by K-Group Beta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Summary
This trial is testing a new combination drug treatment for women with ovarian cancer that has stopped responding to other treatments.
Who is the study for?
This trial is for women aged 18+ with high-grade ovarian, peritoneal, or fallopian tube cancer that's resistant to platinum therapy. They must have relapsed within 6 months of treatment and be willing to provide tissue samples. Participants need measurable disease and good organ function but can't join if they have certain heart conditions, uncontrolled blood pressure, gastrointestinal issues affecting absorption, a history of MDS/AML or are on drugs with TdP risk.Check my eligibility
What is being tested?
The study tests ZN-c3 alone and combined with niraparib in patients with platinum-resistant ovarian cancer. It aims to assess the safety and effectiveness of these treatments while also studying how the body processes them (pharmacokinetics) and their impact on the disease at a cellular level (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include typical reactions from anticancer medications such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding tendencies. Specific side effects related to ZN-c3 or niraparib could emerge during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D
Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib - Objective Response Rate
Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib - Progression Free Survival at 4 months
+2 moreSecondary outcome measures
To evaluate changes in Patient Reported Outcomes (PROs) and quality of life
To further investigate the antitumor activity of ZN-c3 in combination with niraparib and ZN-c3 monotherapy
To investigate the OS of subjects receiving ZN-c3 in combination with niraparib and ZN-c3 monotherapy
+5 moreOther outcome measures
To investigate the PD and downstream effects of ZN-c3 when given in combination with niraparib - Baseline Cyclin E expression
Body Weight Changes
To investigate the PD and downstream effects of ZN-c3 when given in combination with niraparib - Molecular determinants of sensitivity to ZN-c3
Trial Design
2Treatment groups
Experimental Treatment
Group I: ZN-c3 and NiraparibExperimental Treatment2 Interventions
ZN-c3 in combination with Niraparib
Group II: ZN-c3Experimental Treatment1 Intervention
ZN-c3 Monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
K-Group BetaLead Sponsor
5 Previous Clinical Trials
600 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
716 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received previous treatment with a specific type of medication called a WEE1 inhibitor.You have a heart condition that causes heart failure, such as problems with your heart muscle, blocked blood vessels in your heart, damage to your heart valves, high blood pressure affecting your heart, or severe congestive heart failure.You are able and willing to take medication by mouth.You have taken any experimental medication within the last 28 days.You are currently taking medications that have been linked to a heart rhythm problem called TdP (Torsades de Pointes), as listed on crediblemeds.org.You are allergic to drugs that are similar to ZN-c3 and niraparib, or to any of the ingredients in these medications.
Research Study Groups:
This trial has the following groups:- Group 1: ZN-c3
- Group 2: ZN-c3 and Niraparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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