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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
One of the following disease types: Men or women with histologically confirmed metastatic or unresectable breast cancer that is HER2 negative as assessed by 2018 ASCO-CAP guidelines. Trial participants with hormone receptor positive disease must have progression on at least one hormonal therapy and a CDK inhibitor AND be considered a candidate for chemotherapy; OR, Men with metastatic castration resistant prostate cancer with progression on androgen deprivation therapy and at least one additional agent in the metastatic setting; OR, Women with metastatic high grade serous ovarian cancer with progression on at least one chemotherapy agent.
The last radiation therapy (including palliative radiation) must have occurred ≥3 weeks prior to study registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 5 of cycle 1; up to day 5 of cycle 3
Awards & highlights

Study 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 below
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My last radiation therapy was over 3 weeks ago.
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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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My organs and bone marrow are working well.
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I have had a hysterectomy, oophorectomy, or tubal ligation, with documentation.
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My brain metastases have been treated and are stable for over 4 weeks.
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I am using two effective birth control methods if I can have children.
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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 have another cancer type, but it won't affect this trial's treatment.
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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.

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

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 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
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%
Hypokalemia
22%
Cough
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Periorbital infection
11%
Bone pain
11%
Allergic reaction
11%
Weight loss
11%
Tumor pain
11%
Febrile neutropenia
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
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
293 Previous Clinical Trials
24,072 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,187 Patients Enrolled for Ovarian Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,848 Total Patients Enrolled
21 Trials studying Ovarian Cancer
2,786 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what illnesses is Talazoparib most commonly administered?

"Talazoparib is approved to treat refractory peripheral t-cell lymphoma unspecified, malignant neoplasms, and relapsed peripheral t-cell lymphoma."

Answered by AI

Is this examination currently open to new subjects?

"As per clinicaltrials.gov, this study is actively recruiting for participants and was initially posted on April 3rd 2021 before being modified on March 31st 2022."

Answered by AI

Are there any risks associated with utilizing Talazoparib as a therapy?

"Based on the sparse evidence that exists, our team at Power gave Talazoparib a score of 1 to reflect its status as an early-phase trial."

Answered by AI

Are there any additional experiments that have studied Talazoparib?

"At the moment, 65 clinical trials are being conducted with Talazoparib. Out of these studies, 3 have reached Phase 3. While primarily based in Boston Massachusetts, 2345 sites across America provide access to this medication."

Answered by AI

How many participants are being included in this trial?

"Affirmative. Clinicaltrials.gov data indicates that this medical trial is currently accepting volunteers and was most recently modified on March 31st, 2022. 25 individuals are being sought from a singular site."

Answered by AI
~1 spots leftby Jul 2024