ZN-c3 for Platinum-resistant Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Platinum-resistant Ovarian Cancer+3 MoreZN-c3 - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma

Treatment Effectiveness

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: 30 months

12 months
Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib - Progression Free Survival at 4 months
18 months
Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib - Objective Response Rate
30 months
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
To further investigate the antitumor activity of ZN-c3 in combination with niraparib - Objective Response Rate
To investigate the OS of subjects receiving ZN-c3 in combination with niraparib
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
To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Area under the plasma concentration-time curve from 0 to 24h
Plasma Exchange
To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Time to maximum plasma concentration
To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Trough concentration
To investigate the safety and tolerability of ZN-c3 in combination with niraparib
6 months
Phase 1: Incidence and severity of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects during Cycle 1

Trial Safety

Side Effects for

FE Niraparib Fasted
6%Anaemia
6%Urinary tract infection
6%Diarrhoea
6%Blood creatinine increased
6%Decreased appetite
6%Hypokalaemia
6%Hypomagnesaemia
6%Cough
6%Catheter site pain
6%Atrial fibrillation
6%Dry eye
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01847274) in the FE Niraparib Fasted ARM group. Side effects include: Anaemia with 6%, Urinary tract infection with 6%, Diarrhoea with 6%, Blood creatinine increased with 6%, Decreased appetite with 6%.

Trial Design

1 Treatment Group

ZN-c3 and Niraparib
1 of 1

Experimental Treatment

138 Total Participants · 1 Treatment Group

Primary Treatment: ZN-c3 · No Placebo Group · Phase 1 & 2

ZN-c3 and NiraparibExperimental Group · 2 Interventions: Niraparib, ZN-c3 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months

Who is running the clinical trial?

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
5 Previous Clinical Trials
534 Total Patients Enrolled
K-Group BetaLead Sponsor
5 Previous Clinical Trials
534 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have demonstrated relapse within 6 months of platinum therapy.
You have evaluable or measurable disease according to RECIST v1.
You have measurable disease according to RECIST V1.