BET Bromodomain Inhibitor ZEN-3694 for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Malignant Neoplasms+14 More
BET Bromodomain Inhibitor ZEN-3694 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Recurrent Malignant Solid Neoplasm
  • Malignant Neoplasms
  • Advance Directives
  • Metastatic Ovarian Carcinoma
  • Advanced Ovarian Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Stage III Ovarian Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2 years

At pre-treatment, on-treatment, and at progression
Gene expression profiling
At progression
Assess emergent resistant mutations
From initiation of treatment to first response
Objective response rate (ORR)
Year 2
Progression-free survival (PFS)
Time from documentation of tumor response to disease progression
Duration of response (DoR)
Up to 2 years
Analysis of formalin-fixed paraffin-embedded (FFPE) and blood and blood samples
Clinical benefit rate (CBR)
Correlate baseline mutations with treatment response
Correlate changes in ctDNA variant allele frequencies with response
Correlate mutation profiles with tumor sequencing
Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response
Incidence of adverse events
Overall survival (OS)
Treatment-induced changes in phospho-protein signaling

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Malignant Neoplasms

Side Effects for

Physician's Choice Treatment
48%Nausea
43%Fatigue
29%Neutropenia
28%Alopecia
25%Diarrhoea
23%Headache
22%Vomiting
22%Decreased appetite
22%Constipation
22%Palmar-plantar erythrodysaesthesia syndrome
19%Anaemia
17%Pyrexia
16%Cough
15%Dyspnoea
15%Back pain
14%Neutrophil count decreased
14%Abdominal pain
12%Arthralgia
12%Alanine aminotransferase increased
12%Weight decreased
12%Paraesthesia
12%Aspartate aminotransferase increased
11%Pain in extremity
11%Myalgia
10%Upper respiratory tract infection
10%Dizziness
10%Asthenia
10%Leukopenia
10%Rash
9%Dysgeusia
8%Insomnia
8%Dyspepsia
8%Oropharyngeal pain
7%Dry skin
7%Musculoskeletal chest pain
7%Neuropathy peripheral
7%Musculoskeletal pain
7%Anxiety
7%Lacrimation increased
7%Mucosal inflammation
7%Hot flush
6%Thrombocytopenia
6%Bone pain
6%Viral upper respiratory tract infection
6%Pleural effusion
6%Oedema peripheral
6%Peripheral sensory neuropathy
6%Stomatitis
6%Dry mouth
5%Neck pain
4%Non-cardiac chest pain
4%White blood cell count decreased
4%Abdominal pain upper
3%Depression
3%Sinusitis
3%Platelet count decreased
2%Dehydration
2%Nervous system disorder
2%General physical health deterioration
2%Pneumonia
2%Influenza like illness
2%Muscle spasms
2%Deep vein thrombosis
2%Urinary tract infection
1%Cerebrovascular accident
1%Localised oedema
1%Encephalopathy
1%Pathological fracture
1%Discomfort
1%Second primary malignancy
1%Lymphadenectomy
1%Uterine haemorrhage
1%Device related infection
1%Muscular weakness
1%Bronchopneumopathy
1%Colitis
1%Febrile neutropenia
1%Sepsis
1%International normalised ratio increased
1%Malignant pleural effusion
1%Acute promyelocytic leukaemia
1%Pericarditis malignant
1%Salpingo-oophorectomy
1%Staphylococcal bacteraemia
1%Malignant melanoma
1%Cellulitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01945775) in the Physician's Choice Treatment ARM group. Side effects include: Nausea with 48%, Fatigue with 43%, Neutropenia with 29%, Alopecia with 28%, Diarrhoea with 25%.

Trial Design

1 Treatment Group

Treatment (ZEN-3694, talazoparib)
1 of 1
Experimental Treatment

88 Total Participants · 1 Treatment Group

Primary Treatment: BET Bromodomain Inhibitor ZEN-3694 · No Placebo Group · Phase 2

Treatment (ZEN-3694, talazoparib)Experimental Group · 2 Interventions: BET Bromodomain Inhibitor ZEN-3694, Talazoparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,989 Previous Clinical Trials
41,298,970 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
479 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a tumor lesion that is situated in a previously irradiated area.
You have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Patients in Cohort 4 must have KRAS mutated advanced solid tumors
Patients must have received at least one line of systemic therapy in the advanced/metastatic setting

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: October 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.