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PARP Inhibitor
ZEN-3694 + Talazoparib for Cancer
Phase 2
Recruiting
Led By Timothy A Yap
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether a specific drug combination of ZEN-3694 and talazoparib works to shrink tumors in patients with advanced solid tumors. Another aim of this study is to find out if, and how, patients' genes influence their response to this drug combination.
Who is the study for?
Adults with advanced solid tumors that are metastatic or unresectable, where standard treatments have failed. Participants must meet specific health criteria like adequate blood cell counts and organ function, agree to use contraception, and not be pregnant or breastfeeding. Some cohorts require genetic mutations in cancer-related genes (e.g., BRCA1/2 or KRAS). Prior therapies are allowed but with certain time frames for recovery.Check my eligibility
What is being tested?
The trial is testing the combination of ZEN-3694, a BET protein inhibitor which may stop tumor growth by targeting overproduced proteins in cancer cells, and Talazoparib, a PARP enzyme inhibitor that prevents cancer cells from repairing their DNA. The study also examines how patients' genetics affect their response to this treatment.See study design
What are the potential side effects?
Potential side effects include issues related to the body's ability to repair DNA damage which could lead to increased risk of developing new cancers or worsening existing ones. Other common drug-related side effects such as fatigue, nausea, allergic reactions might occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be safely biopsied and at least one tumor that can be measured.
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I am 18 years old or older.
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I have chronic hepatitis B but my viral load is undetectable with treatment.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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 rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response
Incidence of adverse events
+2 moreOther outcome measures
Analysis of formalin-fixed paraffin-embedded and blood and blood samples
Assess emergent resistant mutations
Correlate baseline mutations with treatment response
+5 moreSide effects data
From 2021 Phase 3 trial • 431 Patients • NCT0194577548%
Nausea
43%
Fatigue
29%
Neutropenia
28%
Alopecia
25%
Diarrhoea
23%
Headache
22%
Constipation
22%
Decreased appetite
22%
Vomiting
22%
Palmar-plantar erythrodysaesthesia syndrome
19%
Anaemia
17%
Pyrexia
16%
Cough
15%
Back pain
15%
Dyspnoea
14%
Abdominal pain
14%
Neutrophil count decreased
12%
Aspartate aminotransferase increased
12%
Alanine aminotransferase increased
12%
Weight decreased
12%
Arthralgia
12%
Paraesthesia
11%
Pain in extremity
11%
Myalgia
10%
Dizziness
10%
Leukopenia
10%
Upper respiratory tract infection
10%
Asthenia
10%
Rash
9%
Dysgeusia
8%
Oropharyngeal pain
8%
Dyspepsia
8%
Insomnia
7%
Musculoskeletal pain
7%
Mucosal inflammation
7%
Musculoskeletal chest pain
7%
Lacrimation increased
7%
Dry skin
7%
Hot flush
7%
Neuropathy peripheral
7%
Anxiety
6%
Viral upper respiratory tract infection
6%
Bone pain
6%
Pleural effusion
6%
Thrombocytopenia
6%
Dry mouth
6%
Oedema peripheral
6%
Stomatitis
6%
Peripheral sensory neuropathy
5%
Neck pain
4%
Non-cardiac chest pain
4%
White blood cell count decreased
4%
Abdominal pain upper
3%
Sinusitis
3%
Platelet count decreased
3%
Depression
2%
Influenza like illness
2%
Urinary tract infection
2%
Muscle spasms
2%
General physical health deterioration
2%
Pneumonia
2%
Dehydration
2%
Nervous system disorder
2%
Deep vein thrombosis
1%
Pathological fracture
1%
Muscular weakness
1%
Encephalopathy
1%
Bronchopneumopathy
1%
Febrile neutropenia
1%
Colitis
1%
Localised oedema
1%
Sepsis
1%
Staphylococcal bacteraemia
1%
International normalised ratio increased
1%
Malignant pleural effusion
1%
Acute promyelocytic leukaemia
1%
Malignant melanoma
1%
Pericarditis malignant
1%
Second primary malignancy
1%
Salpingo-oophorectomy
1%
Cerebrovascular accident
1%
Uterine haemorrhage
1%
Lymphadenectomy
1%
Cellulitis
1%
Device related infection
1%
Discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Physician's Choice Treatment
Talazoparib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN-3694, talazoparib)Experimental Treatment5 Interventions
Patients receive ZEN-3694 PO QD and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging throughout the study and undergo blood sample collection and tumor biopsy while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Talazoparib
2021
Completed Phase 2
~2770
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,766 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
448 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that can be safely biopsied and at least one tumor that can be measured.I agree to use contraception during and for 4 months after the study.I have not been treated with ZEN-3694 or any experimental BET inhibitors.My cancer is in an area that was previously treated with radiation.I have a BRCA mutation and my last treatment was with PARP inhibitors.I haven't had bone-targeted radionuclide therapy in the last 6 weeks.I am 18 years old or older.I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.I do not have any unmanaged ongoing illnesses.My advanced cancer has a KRAS mutation and I've had KRAS-targeted treatment if it's G12C.I agree to use birth control or abstain from sex during and for 7 months after the study.My heart is healthy enough for the trial, as per the New York Heart Association standards.I haven't had major surgery, except for diagnosis, dental work, or stenting, in the last 4 weeks.My kidney function is good enough for the trial, with a GFR of at least 60 mL/min/1.73 m^2 or safely lower.I am not taking any blood thinners except for low molecular weight heparin.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.I have another cancer, but it won't affect this trial's treatment.I cannot or will not take pills.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not taking any strong CYP3A4 inhibitors or inducers, or can stop them 7 days before starting ZEN-3694.More than a quarter of my bone marrow has been exposed to radiation.I have a confirmed mutation related to my cancer and agree to share my test results.I can take care of myself but might not be able to do heavy physical work.I have chronic hepatitis B but my viral load is undetectable with treatment.I have had at least one treatment for my advanced cancer, or there are no treatments known to work for my condition.I had brain metastases but am stable now without steroids for 2 weeks.I have a digestive issue that affects how my body absorbs medication.I am 18 years old or older.I am not pregnant or have had surgery or am menopausal to prevent pregnancy.I finished my last cancer treatment over 4 weeks ago and have recovered from its side effects.I do not have an active infection needing IV antibiotics or any severe illness requiring hospitalization.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I am not pregnant or breastfeeding.I am allergic to medications similar to ZEN-3694 or talazoparib.I am HIV positive, on treatment, and my viral load is undetectable.I have a specific gene mutation and my last treatment was with PARPi.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ZEN-3694, 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.
Is the recruitment of participants for this experiment ongoing?
"That is correct. According to information posted on clinicaltrials.gov, this medical trial was initially submitted on August 4th 2022 and has since been updated on November 3rd 2022. The study necessitates 88 participants from a selection of four locations."
Answered by AI
What is the total cohort size of this clinical trial?
"The clinical trial necessitates the recruitment of 88 qualified individuals. Potential participants can join from medical centres like Emory University Hospital/Winship Cancer Institute in Atlanta, Georgia and M D Anderson Cancer Center in Houston, Texas."
Answered by AI
Has the U.S. Food and Drug Administration sanctioned ZEN-3694 as a BET Bromodomain Inhibitor?
"Our evaluative team has granted BET Bromodomain Inhibitor ZEN-3694 a score of 2 due to the fact that, while there is some data suggesting safety, this experiment remains in Phase 2 and therefore lacks efficacy evidence."
Answered by AI
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