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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have platinum-resistant disease
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
Awards & highlights
Study Summary
This trial will test a new drug, ZN-c3, on people with cancer that has spread to other parts of the body. The drug will be given to see if it is effective and safe.
Who is the study for?
This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who've had up to three prior treatments including bevacizumab. They must have a measurable lesion and an ECOG performance status of ≤1. Participants need to agree to contraception use during and after the trial for specified periods.Check my eligibility
What is being tested?
The study tests ZN-c3's effectiveness, safety, how it moves through the body (pharmacokinetics), and its impact on certain biomarkers in patients with specific types of advanced gynecological cancers that have worsened within six months despite treatment.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to drug ingredients or those common in cancer therapies such as fatigue, nausea, blood count changes. Specific side effects will depend on ZN-c3's action mechanism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve with platinum-based chemotherapy.
Select...
I am 18 years old or older.
Select...
I have high-grade serous ovarian cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of TEAEs
Incidence of dose modifications
Overall Response Rate defined by the revised RECIST v1 .1. and assessed by ICR.
+1 moreSecondary outcome measures
Clinical Benefit Rate as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.
Duration of Response as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.
Overall Response Rate as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open-label with ZN-c3 (also known as azenosertib)Experimental Treatment1 Intervention
ZN-c3 (azenosertib) taken orally with food
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Who is running the clinical trial?
K-Group BetaLead Sponsor
5 Previous Clinical Trials
638 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
754 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation therapy in the last 3 weeks.I don't have serious illnesses like recent bowel blockages or need for frequent fluid removal.I haven't had chemotherapy or targeted therapy in the last 14 days or 5 half-lives, whichever is shorter.I have previously been treated with bevacizumab.I have not had major surgery in the last 4 weeks.My condition did not improve with platinum-based chemotherapy.I am 18 years old or older.I have high-grade serous ovarian cancer.I had a stem cell transplant less than 3 months ago.My blood counts and organ functions are within normal ranges.I have had 1 to 4 (or up to 5 in part 1b) previous treatments.I have not taken ZN-c3 or similar drugs targeting cancer cell growth.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label with ZN-c3 (also known as azenosertib)
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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