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ZN-c3 for Ovarian Cancer

Phase 1 & 2
Recruiting
Research Sponsored by K-Group Beta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability and willingness to take oral medication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for women with ovarian cancer that has stopped responding to other treatments.

Eligible Conditions
  • Platinum-resistant Ovarian Cancer
  • Peritoneal Carcinoma
  • Ovarian Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able and willing to take medication by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Incidence and severity of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
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
Secondary 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 - Clinical Benefit Rate
To further investigate the antitumor activity of ZN-c3 in combination with niraparib - Duration of response
+7 more
Other 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

Side effects data

From 2021 Phase 3 trial • 596 Patients • NCT01847274
6%
Vomiting
6%
Nasal congestion
6%
Fatigue
6%
Constipation
6%
Hypokalaemia
6%
Dysphonia
6%
Pyrexia
6%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FE Niraparib Fed
QTc Sub-study: Niraparib
gBRCA Niraparib (Post-study Unblinding [PSU])
gBRCA Placebo (PSU)
Non-gBRCA Niraparib (PSU)
Non-gBRCA Placebo (PSU)
gBRCA Niraparib
gBRCA Placebo
Non-gBRCA Niraparib
Non-gBRCA Placebo
FE Niraparib Fasted

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZN-c3 and NiraparibExperimental Treatment2 Interventions
ZN-c3 in combination with Niraparib
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
590 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
706 Total Patients Enrolled

Media Library

Niraparib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05198804 — Phase 1 & 2
Ovarian Cancer Research Study Groups: ZN-c3 and Niraparib
Ovarian Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05198804 — Phase 1 & 2
Niraparib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198804 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this trial's implementation?

"Ten different study sites are currently accepting participants, such as Aurora's Site 0264, Eugene's Site 0201 and Grand Rapids' Site 0228. Several other medical centres also have open recruitment slots."

Answered by AI

What aims are investigators of this experiment aiming to fulfill?

"The primary assessment for this 18 month long experiment is the incidence and severity of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects during Cycle 1. Secondary targets include a comprehensive review of overall survival, maximum plasma concentration of ZN-c3 and niraparib when given together, as well as an analysis on clinical benefit rate, progression free survival, and 4-month rates according to revised RECIST version 1.1 criteria."

Answered by AI

Is this experiment accepting new participants?

"Affirmative. Clinicaltrials.gov has evidence that this research trial, which was initially posted on the 27th of January 2022, is currently looking for enrolment from 138 participants across 10 sites."

Answered by AI

How many individuals are contributing to this research initiative?

"To carry out the trial, 138 participants that meet the enrolment criteria are necessary. The K-Group Beta sponsor will be running this study from two different designated sites: 0264 in Aurora, Colorado and 0201 in Eugene, Oregon."

Answered by AI
~44 spots leftby Apr 2025