A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer

NCT03901469

Last updated date
Study Location
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , , Spain
Contact
415-470-5600

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Triple Negative Breast Cancer
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

1. Females or males age ≥ 18 years (at time of signing informed consent)

2. Histologically confirmed metastatic or recurrent triple-negative breast cancer (estrogen receptor (ER) ≤10%; progesterone receptor (PR) ≤10%; HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)

3. Part 1: Progressed on at least 1 prior cytotoxic chemotherapy at least 21 days prior to the start of study treatment. Part 2: Progressed on no more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease (no limit on prior targeted anticancer therapies such as mechanistic target or rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF) at least 21 days prior to the start of study treatment.

4. Patient is not a candidate for endocrine based therapy or has progressed on at least 2 prior endocrine based therapies in the locally advanced or metastatic setting

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Part 2 only: Measurable disease per RECIST version 1.1

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


1. Documented germline BRCA1 or BRCA2 mutations


2. Evidence of disease progression during platinum treatment either in the neoadjuvant or
in the metastatic setting. For patients receiving platinum in the neoadjuvant setting,
at least 12 months must have elapsed between the last dose of platinum-based treatment
and enrollment.


3. Patients with inflammatory breast cancer


4. Current or anticipated use of medications known to be strong inhibitors or inducers of
CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors,
inducers or substrates must be discontinued at least 7 days prior to the first
administration of study drug.


5. Current or anticipated use within 7 days prior to the first administration of study
drug, or during the study, of strong P-gp inhibitors. For a list of strong P-gp
inhibitors, refer to Section 8.4.1.


6. Prior anticancer therapy (chemotherapy, radiation, hormone therapy, immunotherapy or
investigational agent) within 3 weeks from the start of study drug (except for
nitrosoureas and mitomycin C within 6 weeks from start of study drug).


7. Have not progressed on prior endocrine therapy and have an ER and/or PR ≥ 1%

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
Official Title  ICMJE A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer
Brief Summary This is two-part open label, non-randomized, Phase 2, study of ZEN003694 in combination with Talazoparib in patients with TNBC without germline mutations of BRCA1 or BRCA2. Part 1 is dose escalation and Part 2 is a Simon 2-Stage design
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Cancer
Intervention  ICMJE
  • Drug: ZEN003694
    Bromodomain Inhibitor
  • Drug: Talazoparib
    PARP Inhibitor
Study Arms  ICMJE Experimental: Experimental: ZEN003694 in Combination with Talazoparib
ZEN003694 will be administered orally once daily with Talazoparib orally once daily in 28-day cycles, enrolling TNBC patients. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2
Interventions:
  • Drug: ZEN003694
  • Drug: Talazoparib
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
49
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Females or males age ? 18 years (at time of signing informed consent)
  2. Histologically confirmed metastatic or recurrent triple-negative breast cancer (estrogen receptor (ER) ?10%; progesterone receptor (PR) ?10%; HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)
  3. Part 1: Progressed on at least 1 prior cytotoxic chemotherapy at least 21 days prior to the start of study treatment. Part 2: Progressed on no more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease (no limit on prior targeted anticancer therapies such as mechanistic target or rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF) at least 21 days prior to the start of study treatment.
  4. Patient is not a candidate for endocrine based therapy or has progressed on at least 2 prior endocrine based therapies in the locally advanced or metastatic setting
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Part 2 only: Measurable disease per RECIST version 1.1

Exclusion Criteria

  1. Documented germline BRCA1 or BRCA2 mutations
  2. Evidence of disease progression during platinum treatment either in the neoadjuvant or in the metastatic setting. For patients receiving platinum in the neoadjuvant setting, at least 12 months must have elapsed between the last dose of platinum-based treatment and enrollment.
  3. Patients with inflammatory breast cancer
  4. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.
  5. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors. For a list of strong P-gp inhibitors, refer to Section 8.4.1.
  6. Prior anticancer therapy (chemotherapy, radiation, hormone therapy, immunotherapy or investigational agent) within 3 weeks from the start of study drug (except for nitrosoureas and mitomycin C within 6 weeks from start of study drug).
  7. Have not progressed on prior endocrine therapy and have an ER and/or PR ? 1%
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zenith Study Team415-470-5600[email protected]
Listed Location Countries  ICMJE Belgium,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901469
Other Study ID Numbers  ICMJE ZEN003694-004
2018-003906-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Zenith Epigenetics
Study Sponsor  ICMJE Zenith Epigenetics
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Zenith Epigenetics
Verification Date December 2019

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