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Metastatic Breast CancerPhase 1NCT04703920

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

A Phase 1 study testing Talazoparib and Belinostat in people with Metastatic Breast Cancer and Metastatic Castration-resistant Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 1 dose-escalation trial is to determine the safety, tolerability and recommended phase 2 dose of talazoparib in combination with belinostat in subjects with Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Talazoparib and Belinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
4 Mar 2021to 2 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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; OR, men or women with metastatic or unresectable pancreatic adenocarcinoma with progression on at least one chemotherapy regimen in the metastatic/unresectable setting
  • Measurable disease as defined by RECIST 1.1 criteria.
  • Trial participants must be at least 21 days from last dose of chemotherapy and recovered from all chemotherapy-related reversible toxicity to Grade 0 or 1, with the exception of alopecia and neuropathy.
  • The last radiation therapy (including palliative radiation) must have occurred ≥3 weeks prior to study registration.
  • Trial participants must have experienced disease progression at the time of study enrollment.
  • ECOG performance status of 0 or 1.
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  • Adequate organ and marrow function per protocol.
  • Trial participants with treated brain metastases are eligible provided the metastases are recently treated and/or clinically stable and greater than 4 weeks has elapsed from time of treatment and date of initiation of study drug.
  • Trial participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
  • Males and females of reproductive potential must use two forms of effective contraception during the duration of the trial and for minimum of 7 months after last dose of study drug. A woman of reproductive potential is defined as a premenopausal female with intact uterus and ovaries. For women, non-childbearing potential is defined as:
  • ≥45 years of age and has not had menses for >2 years.
  • Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
  • Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
  • Ability to understand and the willingness to sign a written informed consent.

Who cannot join

  • Previous or current treatment with a histone deacetylase inhibitor (HDACi)S.
  • Participation in other investigational studies concurrently if these therapies include a therapeutic intervention.
  • Treatment with any investigational agent within 30 days (or 5 serum half-lives of the investigational drug, whichever is longer) of enrollment.
  • Evidence of current serious uncontrolled concomitant cardiovascular nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
  • Myocardial infarction or arterial thromboembolic events within 6 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 450 msec.
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  • Uncontrolled hypertension or diabetes mellitus.
  • Another known malignancy that is progressing or requires active treatment.
  • Active infection requiring systemic therapy.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Any contraindication to oral agents or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption.
  • Allergy to talazoparib, belinostat or to the inactive components of talazoparib or belinostat formulations.
  • Pregnancy or breastfeeding.
  • QTc ≥ 450 ms or congenital long QT syndrome given potential for prolongation with belinostat.
  • Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study of drugs which are moderate or strong inhibitors of UGT1A1 per protocol.
  • Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study, of strong P-gp inhibitors per protocol.
  • Subjects homozygous for UGT1A1*28 allele; this will be determined via clinical testing by polymerase chain reaction with capillary electrophoresis by the University of Michigan Molecular Diagnostics laboratory.
  • Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Trial of Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

This Phase 1 dose-escalation trial is to determine the safety, tolerability and recommended phase 2 dose of talazoparib in combination with belinostat in subjects with Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer.

Being tested
Talazoparib, Belinostat
Keywords
PARP inhibitor
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalazoparibDrug

    Talazoparib will be administered in increasing doses up to 1 mg orally once a day.

  • BelinostatDrug

    Belinostat will be administered in increasing doses up to 1000 mg/m2 IV once daily on days 1-5 of a 21-day cycle.

Study groups in NCT04703920
Study groupRoleWhat they receive
Talozoparib in combination with BelinostatExperimentalPatients will receive Talozoparib in combination with Belinostat
Receives: Drug: Talazoparib; Drug: Belinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLT) within the first two cycles of treatment

    Number of DLT's experienced by participants within the first two cycles. A DLT will be defined as any treatment related toxicity of grade 3 or 4 unless otherwise defined in the protocol. DLTs will be assessed via the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 10 weeks

Secondary outcomes (4)

  1. Proportion of patients experiencing toxicities. Participants may continue to receive the investigational study therapy until disease progression or unacceptable toxicity.

    The proportion of patients experiencing toxicities will be reported by dose level and grade. Toxicities and grading per the NCI CTCAE version 5.0.

    Measured: Up to 30 days post last treatment, up to approximately 6 months

  2. Plasma concentrations of talazoparib at steady state

    Plasma concentrations of talazoparib at steady state will be measured to evaluate its pharmacokinetic (PK) profile, with combination therapy of talazoparib and belinostat. Sparse PK assessment will occur at multiple time points from day 5 of cycle 1 through day 5 of cycle 3 in order to assess steady-state trough levels. The plasma concentrations will be determined by liquid chromatography, high-resolution mass spectrometry, and summarized descriptively by dose level.

    Measured: Day 5 of cycle 1; up to day 5 of cycle 3

  3. Plasma concentrations of belinostat at steady state

    Plasma concentrations of belinostat at steady state will be measured to evaluate its PK profile, with combination of talazoparib and belinostat. Sparse PK assessment will occur at multiple time points from day 5 of cycle 1 through day 5 of cycle 3 in order to assess steady-state trough levels. The plasma concentrations will be determined by liquid chromatography, high-resolution mass spectrometry, and summarized descriptively by dose level.

    Measured: Day 5 of cycle 1; up to day 5 of cycle 3

  4. Number of patients with an objective response

    Number of patients with an objective response per the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 will be reported by dose level.

    Measured: Up to 30 days post last treatment, up to approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start4 Mar 2021
  3. Primary completion1 Dec 2024
  4. Study completion2 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04703920
Sponsor's protocol ID
UMCC 2020.122
Other IDs
HUM00187603
Status last verified
Jan 2025
First submitted
8 Jan 2021
Last updated
23 Jan 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Talazoparib and Belinostat in people with Metastatic Breast Cancer and Metastatic Castration-resistant Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLT) within the first two cycles of treatment (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04703920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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