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PARP Inhibitor

ZEN-3694 + Talazoparib for Cancer

University of Virginia Cancer Center, Charlottesville, VA
BET Bromodomain Inhibitor ZEN-3694 +4 morePhase 2RecruitingLed by Timothy A YapResearch Sponsored by National Cancer Institute (NCI)

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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more
Other outcome measures
Analysis of formalin-fixed paraffin-embedded and blood and blood samples
Assess emergent resistant mutations
Correlate baseline mutations with treatment response
+5 more

Side effects data

From 2021 Phase 3 trial • 431 Patients • NCT01945775
48%
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%
Upper respiratory tract infection
10%
Leukopenia
10%
Asthenia
10%
Dizziness
10%
Rash
9%
Dysgeusia
8%
Oropharyngeal pain
8%
Dyspepsia
8%
Insomnia
7%
Mucosal inflammation
7%
Musculoskeletal chest pain
7%
Lacrimation increased
7%
Musculoskeletal pain
7%
Dry skin
7%
Hot flush
7%
Neuropathy peripheral
7%
Anxiety
6%
Viral upper respiratory tract infection
6%
Pleural effusion
6%
Thrombocytopenia
6%
Dry mouth
6%
Oedema peripheral
6%
Bone pain
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%
Urinary tract infection
2%
Influenza like illness
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1180
Biospecimen Collection
2004
Completed Phase 1
~1540
Talazoparib
2021
Completed Phase 2
~2750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,487 Previous Clinical Trials
41,266,683 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
448 Total Patients Enrolled

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05327010 — Phase 2
Cancer Research Study Groups: Treatment (ZEN-3694, talazoparib)
Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT05327010 — Phase 2
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327010 — Phase 2

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, Georgiap 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
Recent research and studies
clinicaltrials.govStudy
Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
2022. "Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327010.
~55 spots leftby Aug 2025
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