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Histone Deacetylase Inhibitor

Talazoparib + Belinostat for Metastatic Cancer

Phase 1
Waitlist Available
Led By Monica Burness, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Trial participants must have experienced disease progression at the time of study enrollment.
ECOG performance status of 0 or 1.
Must not have
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Uncontrolled hypertension or diabetes mellitus.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 5 of cycle 1; up to day 5 of cycle 3
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat metastatic breast, prostate, and ovarian cancers. They want to see if it is safe and what the best dose is.

Who is the study for?
This trial is for adults with certain advanced cancers: HER2-negative breast cancer after hormone therapy and a CDK inhibitor, metastatic prostate cancer resistant to hormone therapy, or high-grade serous ovarian cancer after chemotherapy. Participants must have stable health, no recent major treatments like chemotherapy (except for brain metastases treatment), and be able to consent. They should not be on strong P-gp inhibitors, have had HDACi treatment, or have serious uncontrolled diseases.
What is being tested?
The study tests the combination of two drugs, Talazoparib and Belinostat, in patients with specific types of metastatic cancers. It's a Phase 1 trial focused on finding the safest dose that can be given without causing severe side effects (dose-escalation).
What are the potential side effects?
Potential side effects include nausea and vomiting due to both drugs; Talazoparib may cause blood cell count issues or fatigue; Belinostat might lead to heart rhythm problems (QTc prolongation) or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition has worsened recently.
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I am fully active or can carry out light work.
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I have had a hysterectomy, oophorectomy, or tubal ligation, with documentation.
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I have not had periods for less than 2 years without surgical removal of my uterus and ovaries, and my hormone levels indicate I am postmenopausal.
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I am over 45 and have not had a period in more than 2 years.
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I am 21 days past my last chemotherapy and have recovered from its side effects, except for hair loss and nerve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain or surrounding membranes.
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I do not have uncontrolled high blood pressure or diabetes.
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I have another cancer that is getting worse or needs treatment.
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I haven't had a heart attack or severe heart issues in the last 6 months.
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I am not using, and do not plan to use strong P-gp inhibitors soon.
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I have been treated with a histone deacetylase inhibitor.
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I do not have any uncontrolled serious health conditions.
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I am currently on medication for an infection.
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My heart's electrical cycle is longer than normal.
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I am not using, and do not plan to use, certain drugs that affect UGT1A1 during the study.
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My test shows I have two copies of the UGT1A1*28 gene variant.
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I am not allergic to talazoparib, belinostat, or their inactive ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 5 of cycle 1; up to day 5 of cycle 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 5 of cycle 1; up to day 5 of cycle 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicities (DLT) within the first two cycles of treatment
Secondary study objectives
Number of patients with an objective response
Plasma
Plasma concentrations of talazoparib at steady state
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
100%
Fatigue
100%
Headache
67%
Platelet count decreased
67%
Hyperglycemia
67%
Anemia
67%
Back pain
33%
Alopecia
33%
Weight loss
33%
Nausea
33%
Sinus tachycardia
33%
Investigations - Other, BUN DECREASED
33%
Urinary incontinence
33%
Peripheral motor neuropathy
33%
Hyponatremia
33%
Hypoglycemia
33%
Hypothyroidism
33%
Neutrophil count decreased
33%
White blood cell decreased
33%
Scoliosis
33%
Hypokalemia
33%
Insomnia
33%
Creatinine increased
33%
Alanine aminotransferase increased
33%
Peripheral sensory neuropathy
33%
Fever
33%
Diarrhea
33%
Hypermagnesemia
33%
Lymphocyte count decreased
33%
Hypophosphatemia
33%
Gastroesophageal reflux disease
33%
Skin ulceration
33%
Nervous system disorders - Other, PARALYSIS
33%
Muscle weakness lower limb
33%
Cough
33%
Non-cardiac chest pain
33%
Skin infection
33%
Nystagmus
33%
Arthralgia
33%
Gait disturbance
33%
Edema limbs
33%
Hypertension
33%
Investigations - Other, ALT DECREASED
33%
Chills
33%
Investigations - Other, AST DECREASED
33%
Nervous system disorders - Other, HYPOTONIC
33%
Aspartate aminotransferase increased
33%
Blurred vision
33%
Constipation
33%
Pain in extremity
33%
Alkaline phosphatase increased
33%
Neuralgia
33%
Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA
33%
Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

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: Talozoparib in combination with BelinostatExperimental Treatment2 Interventions
Patients will receive Talozoparib in combination with Belinostat
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belinostat
2006
Completed Phase 2
~430
Talazoparib
2021
Completed Phase 2
~2810

Find a Location

Who is running the clinical trial?

Acrotech Biopharma LLCIndustry Sponsor
27 Previous Clinical Trials
3,814 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,339 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,324 Patients Enrolled for Ovarian Cancer
PfizerIndustry Sponsor
4,660 Previous Clinical Trials
17,877,288 Total Patients Enrolled
21 Trials studying Ovarian Cancer
2,626 Patients Enrolled for Ovarian Cancer

Media Library

Belinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04703920 — Phase 1
Ovarian Cancer Research Study Groups: Talozoparib in combination with Belinostat
Ovarian Cancer Clinical Trial 2023: Belinostat Highlights & Side Effects. Trial Name: NCT04703920 — Phase 1
Belinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04703920 — Phase 1
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