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

NCT04703920

Last updated date
Study Location
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Ovarian Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- 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.

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Metastatic Breast Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Ovarian CarcinomaTalazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
NCT04703920
  1. Ann Arbor, Michigan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Metastatic Castration-resistant Prostate Cancer
  • Metastatic Ovarian Carcinoma
Intervention  ICMJE
  • Drug: Talazoparib
    Talazoparib will be administered in increasing doses up to 1 mg orally once a day.
  • Drug: Belinostat
    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 Arms  ICMJE Experimental: Talozoparib in combination with Belinostat
Patients will receive Talozoparib in combination with Belinostat
Interventions:
  • Drug: Talazoparib
  • Drug: Belinostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2021)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.
  • 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.

Exclusion Criteria:

  • 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.
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04703920
Other Study ID Numbers  ICMJE UMCC 2020.122
HUM00187603 ( Other Identifier: University of Michigan )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE
  • Pfizer
  • Acrotech Biopharma LLC
Investigators  ICMJE
Principal Investigator:Monica Burness, M.D.University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP