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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion, approximately 40 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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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.
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My cancer is a high-grade serous type in the ovary, fallopian tube, or peritoneum.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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, or gemcitabine
Secondary outcome measures
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 outcome measures
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 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Combination with paclitaxelExperimental Treatment2 Interventions
Participants will take: (1) ZN-c3 orally and continuously once daily (QD) in 28-day treatment cycles, and (2) paclitaxel 80 mg/m^2 administered intravenously over 60 minutes (± 10 minutes) on Days 1, 8, and 15 of each 28-day cycle
Group II: Combination with gemcitabineExperimental Treatment2 Interventions
Participants will take: (1) ZN-c3 orally and continuously once daily (QD) in 21-day treatment cycles, and (2) gemcitabine 1000 mg/m^2 intravenously over 30 minutes or longer every 3 weeks, on Day 1 of each 21-day cycle. If the dose of 1000 mg/m2 is deemed to have unacceptable toxicity in combination with ZN-c3, lower doses may be assessed.
Group III: Combination with carboplatinExperimental Treatment2 Interventions
Participants will take: (1) ZN-c3 orally and continuously once daily (QD) in 21-day treatment cycles (± 3 days), and (2) carboplatin 5 mg/mL*min intravenously over 15 minutes or longer every 3 weeks, on Day 1 of each 21-day cycle (± 3 days)
Group IV: Combination with PLDExperimental Treatment2 Interventions
Participants will take: (1) ZN-c3 orally and continuously once daily (QD) in 28-day treatment cycles (± 3 days), and (2) PLD 40 mg/m^2 intravenously over 60 minutes every 4 weeks, on Day 1 of each 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Pegylated liposomal doxorubicin
2005
Completed Phase 4
~2260
Carboplatin
2014
Completed Phase 3
~6670
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
K-Group BetaLead Sponsor
5 Previous Clinical Trials
588 Total Patients Enrolled
1 Trials studying Ovarian Cancer
138 Patients Enrolled for Ovarian Cancer
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
704 Total Patients Enrolled
1 Trials studying Ovarian Cancer
138 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 paclitaxel
- Group 2: Combination with PLD
- Group 3: Combination with gemcitabine
- Group 4: 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
From how many central points is this research coordinated?
"To limit participant burden, the clinical trial sites were chosen to be in close proximity to 4 major metropolitan areas. The cities with sites are Nashville, Boston, Houston, and 4 other locations."
Answered by AI
Does this type of research project have any precedent?
"Alfacell conducted the first study on ZN-c3 in 1997, which then allowed the drug to enter Phase 3 clinical trials. Presently, there are 1756 active trials in 3860 cities and 89 countries."
Answered by AI
What is the maximum number of people who can take part in this trial?
"One hundred and forty patients are required for this clinical trial to have the desired sample size. K-Group Beta, the sponsor of this study, will be conducting the trial at different locations. For example, Site 0196 in Nashville, Tennessee and Site 0104 in Boston, Massachusetts."
Answered by AI
By what margin does this trial hope to improve patient outcomes?
"The main objective of this trial is to investigate the safety and tolerability of ZN-c3 in combination with PLD and with carboplatin, respectively. Secondary outcomes include obtaining estimates of clinical activity by determining the duration of response (DOR) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine, which is defined as Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1, To obtain estimates of clinical activity by determining the progression-free survival (PFS) of"
Answered by AI
What medical purposes does ZN-c3 usually serve?
"ZN-c3 can be used to treat various cancers, such as non-hodgkin lymphoma, Kaposi's sarcoma, and non-small cell lung cancer."
Answered by AI
Are there other ZN-c3 studies that have previously been completed?
"ZN-c3 was first studied in 1997 at the Spectrum Health Hospital - Butterworth Campus. As of now, there have been a total of 2700 completed clinical trials. Out of these, 1756 are live studies. A large number of these ongoing trials are taking place in Nashville, Tennessee."
Answered by AI
What is the ZN-c3's current standing with the FDA?
"ZN-c3 is still in early testing, so limited data is available to support its efficacy and safety."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Site 0196
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have peritoneal carcinomatous. I had ovarian cancer in 2019, it has now spread to my abdomen.
PatientReceived 1 prior treatment
I have peritoneal carcinomatous. I had ovarian cancer in 2019, it has now spread to my abdomen. My oncologist wants to treat me with chemo.,, Not sure that is the correct treatment. Feel that that treatment will not really help me.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Site 0196: < 48 hours
Average response time
- < 2 Days
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