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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2.
Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test and agree to use an effective method of contraception per institutional standard.
Must not have
Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion, approximately 40 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug (ZN-c3) to see if it is safe and works well with other drugs.
Who is the study for?
This trial is for women over 18 with high-grade serous ovarian, fallopian tube, or peritoneal carcinoma that's resistant to platinum-based therapy. They must have had 1-2 prior treatments and measurable disease. Participants need proper organ function, a negative pregnancy test, and agree to use contraception.
What is being tested?
The study tests ZN-c3 in combination with other cancer drugs (Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine) on patients with platinum-resistant ovarian cancer. It aims to assess safety, tolerability and preliminary effectiveness of the drug mix.
What are the potential side effects?
Potential side effects may include reactions related to each drug such as nausea from chemotherapy agents like Carboplatin or nerve damage from drugs like Paclitaxel. The specific side effects of ZN-c3 are being studied but could be similar.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and do some daily activities.
Select...
I am a woman who can have children, have a negative pregnancy test, and will use birth control.
Select...
I have had 1 or 2 treatments for my advanced or metastatic cancer.
Select...
My cancer is a high-grade serous type in the ovary, fallopian tube, or peritoneum.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, or have a positive pregnancy test.
Select...
I do not have another cancer that is spreading or needs treatment.
Select...
I can stop taking certain medications or supplements for the required time before starting the trial.
Select...
My cancer is either an abdominal adenocarcinoma of unknown origin or a borderline ovarian tumor.
Select...
I have a history of long QT syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion, approximately 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion, approximately 40 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab
Secondary study objectives
To investigate the plasma pharmacokinetics (PK) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
To obtain estimates of clinical activity by determining the duration of response (DOR) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
To obtain estimates of clinical activity by determining the objective response rate (ORR) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
+2 moreOther study objectives
To characterize the PK of ZN-c3 in tumor tissue
Cyclin E
To investigate the pharmacodynamics of ZN-c3 on molecular determinants of sensitivity to ZN-c3
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Combination with paclitaxelExperimental Treatment2 Interventions
combined with azenosertib
Group II: Combination with gemcitabineExperimental Treatment2 Interventions
combined with azenosertib
Group III: Combination with carboplatinExperimental Treatment2 Interventions
combined with azenosertib
Group IV: Combination with bevacizumabExperimental Treatment2 Interventions
combined with azenosertib
Group V: Combination with PLDExperimental Treatment2 Interventions
combined with azenosertib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Pegylated liposomal doxorubicin
2005
Completed Phase 4
~2710
Paclitaxel
2011
Completed Phase 4
~5450
Gemcitabine
2017
Completed Phase 3
~1920
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
K-Group BetaLead Sponsor
5 Previous Clinical Trials
525 Total Patients Enrolled
1 Trials studying Ovarian Cancer
117 Patients Enrolled for Ovarian Cancer
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
641 Total Patients Enrolled
1 Trials studying Ovarian Cancer
117 Patients Enrolled for Ovarian Cancer
Philippe Pultar, MDStudy DirectorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
2 Previous Clinical Trials
490 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, or have a positive pregnancy test.I do not have another cancer that is spreading or needs treatment.I am a woman over 18 or the legal adult age in my country.My blood and organs are functioning well.I can take care of myself and do some daily activities.I am a woman who can have children, have a negative pregnancy test, and will use birth control.I have had 1 or 2 treatments for my advanced or metastatic cancer.My cancer did not respond well to platinum-based treatment within 6 months.Your ECG shows a specific measurement called corrected QT interval (QTcF) that is longer than 480 milliseconds, unless you have certain heart conditions that affect this measurement.I can stop taking certain medications or supplements for the required time before starting the trial.My cancer is a high-grade serous type in the ovary, fallopian tube, or peritoneum.My cancer is either an abdominal adenocarcinoma of unknown origin or a borderline ovarian tumor.I have a history of long QT syndrome.I have not had certain treatments before starting the trial.Your disease can be measured using a specific set of guidelines called RECIST version 1.1.I have a serious illness or medical condition.My heart's pumping ability is normal or near normal.
Research Study Groups:
This trial has the following groups:- Group 1: Combination with bevacizumab
- Group 2: Combination with paclitaxel
- Group 3: Combination with PLD
- Group 4: Combination with gemcitabine
- Group 5: Combination with carboplatin
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.
Ovarian Cancer Patient Testimony for trial: Trial Name: NCT04516447 — Phase 1
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