Your session is about to expire
← Back to Search
Histone Deacetylase Inhibitor
Talazoparib + Belinostat for Metastatic Cancer
Phase 1
Recruiting
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
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.Check my eligibility
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).See study design
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 belowSelect...
My condition has worsened recently.
Select...
I am fully active or can carry out light work.
Select...
I have had a hysterectomy, oophorectomy, or tubal ligation, with documentation.
Select...
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.
Select...
I am over 45 and have not had a period in more than 2 years.
Select...
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:Select...
I have cancer that has spread to my brain or surrounding membranes.
Select...
I do not have uncontrolled high blood pressure or diabetes.
Select...
I have another cancer that is getting worse or needs treatment.
Select...
I haven't had a heart attack or severe heart issues in the last 6 months.
Select...
I am not using, and do not plan to use strong P-gp inhibitors soon.
Select...
I have been treated with a histone deacetylase inhibitor.
Select...
I do not have any uncontrolled serious health conditions.
Select...
I am currently on medication for an infection.
Select...
My heart's electrical cycle is longer than normal.
Select...
I am not using, and do not plan to use, certain drugs that affect UGT1A1 during the study.
Select...
My test shows I have two copies of the UGT1A1*28 gene variant.
Select...
I am not allergic to talazoparib, belinostat, or their inactive ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 5 of cycle 1; up to day 5 of cycle 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 5 of cycle 1; up to day 5 of cycle 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLT) within the first two cycles of treatment
Secondary outcome measures
Number of patients with an objective response
Plasma
Plasma concentrations of talazoparib at steady state
+1 moreSide effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT0211677789%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Febrile neutropenia
11%
Allergic reaction
11%
Bone pain
11%
Edema limbs
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Tumor pain
11%
Weight loss
11%
Periorbital infection
11%
Irregular menstruation
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/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+40mg/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 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
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
Talazoparib
2021
Completed Phase 2
~2770
Belinostat
2006
Completed Phase 2
~430
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
295 Previous Clinical Trials
24,265 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,192 Patients Enrolled for Ovarian Cancer
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,745 Total Patients Enrolled
21 Trials studying Ovarian Cancer
2,621 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a hysterectomy, oophorectomy, or tubal ligation, with documentation.I have cancer that has spread to my brain or surrounding membranes.I do not have uncontrolled high blood pressure or diabetes.My last radiation therapy was over 3 weeks ago.My condition has worsened recently.I have another cancer that is getting worse or needs treatment.I am fully active or can carry out light work.My organs and bone marrow are working well.My brain metastases have been treated and are stable for over 4 weeks.I am using two effective birth control methods if I can have children.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.I haven't had a heart attack or severe heart issues in the last 6 months.I have another cancer type, but it won't affect this trial's treatment.I am over 45 and have not had a period in more than 2 years.I am not currently in a clinical trial that involves treatment.I am not using, and do not plan to use strong P-gp inhibitors soon.I have been treated with a histone deacetylase inhibitor.I do not have any uncontrolled serious health conditions.I am currently on medication for an infection.I can take pills without significant issues like severe nausea or problems absorbing medication.My heart's electrical cycle is longer than normal.I am not using, and do not plan to use, certain drugs that affect UGT1A1 during the study.My test shows I have two copies of the UGT1A1*28 gene variant.I am 21 days past my last chemotherapy and have recovered from its side effects, except for hair loss and nerve issues.I am not allergic to talazoparib, belinostat, or their inactive ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Talozoparib in combination with Belinostat
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.
Share this study with friends
Copy Link
Messenger