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PARP Inhibitor
ZEN003694 + Talazoparib for Ovarian Cancer
Phase 2
Recruiting
Led By Haider Mahdi, MD
Research Sponsored by Haider Mahdi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known BRCA1/2 status
Prior therapy with PARPi either as maintenance or therapeutic settings
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of talazoparib and ZEN003694 in women with ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment.
Who is the study for?
This trial is for women over 18 with recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Participants must have had prior therapy with PARPi, any number of previous cancer treatments, measurable disease, known BRCA1/2 status and meet specific health criteria including adequate blood counts and organ function. They cannot be pregnant or breastfeeding and must use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests the combination of two oral drugs: ZEN003694 and Talazoparib given daily in cycles lasting 28 days to treat recurrent ovarian cancer. It's an open-label Phase 2 trial which means everyone gets the treatment and knows what they are receiving.See study design
What are the potential side effects?
While not explicitly listed in your information provided, common side effects for similar cancer therapies may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver function changes, digestive issues and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I know my BRCA1/2 gene status.
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I have been treated with PARP inhibitors before.
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I am a woman aged 18 or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My ovarian cancer has come back, regardless of its response to platinum-based chemotherapy.
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I have been diagnosed with cancer in my ovary, fallopian tube, or the lining of my abdomen.
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I am not breastfeeding and will not breastfeed during the study or for 7 months after.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response
Secondary outcome measures
Adverse events at least possibly related to treatment
Duration of Response
Overall survival (OS)
+1 moreSide effects data
From 2019 Phase 1 & 2 trial • 75 Patients • NCT0271195675%
Visual impairment
25%
Haematuria
25%
Fatigue
25%
Weight decreased
25%
Enterococcal bacteraemia
25%
Pathological fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE A+B 36 mg ZEN003694 + Enzalutamide
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
DE A+B 60 mg ZEN003694 + Enzalutamide
DE A+B 72 mg ZEN003694 + Enzalutamide
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
DE A+B 120 mg ZEN003694 + Enzalutamide
DE A+B 144 mg ZEN003694 + Enzalutamide
Trial Design
1Treatment groups
Experimental Treatment
Group I: ZEN003694 + TalazoparibExperimental Treatment2 Interventions
ZEN003694: 48.0 mg daily (oral) in 28-day cycles
Talazoparib: 0.75 mg daily (oral) at the same time as ZEN003694
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZEN003694
2016
Completed Phase 2
~120
Talazoparib
2021
Completed Phase 2
~2770
Find a Location
Who is running the clinical trial?
Haider MahdiLead Sponsor
5 Previous Clinical Trials
160 Total Patients Enrolled
3 Trials studying Ovarian Cancer
90 Patients Enrolled for Ovarian Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,952 Total Patients Enrolled
20 Trials studying Ovarian Cancer
2,753 Patients Enrolled for Ovarian Cancer
Zenith EpigeneticsIndustry Sponsor
9 Previous Clinical Trials
579 Total Patients Enrolled
1 Trials studying Ovarian Cancer
26 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone any number of cancer treatments.I haven't had chemotherapy or radiation in the last 3 weeks.I have not had a heart attack or unstable chest pain in the last 6 months.I know my BRCA1/2 gene status.More than a quarter of my bone marrow has been exposed to radiation.I haven't had bone-targeted radionuclide therapy in the last 6 weeks.I have been treated with PARP inhibitors before.I am a woman aged 18 or older.I am able to have children, will take a pregnancy test before starting the study drug, and agree to ongoing tests.I don't have any active cancer needing treatment, except for certain skin cancers or cervical cancer in situ.You have a detectable disease according to specific medical guidelines.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major surgery, except for diagnosis, dental work, or stenting, in the last 4 weeks.Your blood tests should show: Hemoglobin level of at least 9.0 gm/dL, Neutrophil count of at least 1.5 × 109/L, Platelet count of at least 150,000/mm3, Liver enzyme levels within the specified range, Bilirubin level within the specified range, Creatinine level within the specified range, and Normal blood clotting test results.I am taking blood thinners, but not oral Factor Xa or IIa inhibitors.I had brain metastases, treated and stable for 6 months without steroids.I do not have any major health issues that could affect my safety or participation in the study.I don't have active HIV, Hepatitis B, or C, or it's under control.I am not able to have children, use effective birth control, or am post-menopausal.My ovarian cancer has come back, regardless of its response to platinum-based chemotherapy.I do not have serious heart problems like uncontrolled arrhythmia or severe heart failure.I have been treated with an experimental BET inhibitor before.I do not have any non-healing wounds, ulcers, or bone fractures.I have been diagnosed with myelodysplastic syndrome.I have been diagnosed with cancer in my ovary, fallopian tube, or the lining of my abdomen.I am not breastfeeding and will not breastfeed during the study or for 7 months after.I can swallow pills and follow study rules.I have a digestive issue that affects how my body absorbs medication.My brain metastases have been stable or treated for at least 6 months.I am not using, nor plan to use strong P-gp inhibitors before or during the study.Your heart's QTcF interval is longer than 470 milliseconds.I have been diagnosed with ovarian carcinosarcoma.I have recovered from previous cancer treatment side effects, except for hair loss, tiredness, or mild nerve pain.I am not currently using, nor plan to use, strong medication that affects enzyme CYP3A4 or CYP1A2.
Research Study Groups:
This trial has the following groups:- Group 1: ZEN003694 + Talazoparib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What constitutes the upper limit of participants in this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this experimental research is currently accruing patients. The trial was initially published on April 27th 2022 and has been recently renewed as of that same date; 33 candidates will be accepted from a single study centre."
Answered by AI
Would any individuals be eligible to join the current iteration of this experiment?
"Clinicaltrials.gov states that this medical trial is still recruiting participants; the original post was dated April 27th 2022 and it has since been updated on the same day."
Answered by AI
What potential risks could be associated with ingesting ZEN003694?
"Our team at Power has given ZEN003694 a safety rating of 2, as the Phase 2 trial hasn't been able to collect enough efficacy data yet."
Answered by AI
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