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A Study of ZN-c5 in Subjects With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560531
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date April 28, 2023
Actual Study Start Date  ICMJE December 8, 2018
Actual Primary Completion Date April 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy [ Time Frame: 9 months ]
  • Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 when administered in combination with palbociclib [ Time Frame: 9 months ]
  • Phase 1 EXP: Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events [ Time Frame: 9 months ]
    Measured by the number of treatment-emergent adverse events
  • Phase 2: Determine preliminary anti-tumor efficacy (Clinical Benefit Rate [CBR]) for ZN-c5 as a monotherapy [ Time Frame: Through study completion (approximately 2 years) ]
  • Phase 2: Determine preliminary anti-tumor efficacy (CBR) for ZN-c5 when administered in combination with palbociclib [ Time Frame: Through study completion (approximately 2 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy [ Time Frame: 9 months ]
  • Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 when administered in combination with palbociclib [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events [ Time Frame: Through study completion (approximately 2 years) ]
    Measured by the number of treatment-emergent adverse events
  • Safety and tolerability of ZN-c5 in combination with palbociclib as measured by number of treatment emergent adverse events [ Time Frame: Through study completion (approximately 2 years) ]
    Measured by the number of treatment-emergent adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events [ Time Frame: Through study completion (approximately 2 years) ]
    Measured by the number of treatment-emergent adverse events
  • Safety and tolerability of ZN-c5 in combination with palbociclib as measured by number of treatment-emergent adverse events [ Time Frame: through study completion (approximately 2 years) ]
    Measured by the number of treatment-emergent adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ZN-c5 in Subjects With Breast Cancer
Official Title  ICMJE A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
Brief Summary This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation cohorts are planned in monotherapy and combination as well as monotherapy dose expansion, and monotherapy and combination Phase 2.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: ZN-c5
    ZN-c5 is a study drug
  • Drug: Palbociclib
    Palbociclib (IBRANCE®) is an approved drug
    Other Name: IBRANCE®
Study Arms  ICMJE
  • Experimental: ZN-c5 monotherapy
    Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.
    Intervention: Drug: ZN-c5
  • Experimental: ZN-c5 + palbociclib combination therapy
    Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.
    Interventions:
    • Drug: ZN-c5
    • Drug: Palbociclib
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2022)		 181
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2018)		 85
Actual Study Completion Date  ICMJE December 22, 2022
Actual Primary Completion Date April 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years of age

    • Women can be postmenopausal, as defined by at least one of the following:
    • Age ≥ 60 years;
    • Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and FSH level within the laboratory's reference range for postmenopausal females;
    • Documented bilateral oophorectomy;
    • Can be peri- or premenopausal, however, they must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication.
  • Histologically or cytologically confirmed diagnosis of advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention
  • Estrogen Receptor (ER) positive disease
  • Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
  • Documented prior response to endocrine therapy for metastatic disease (SD, PR, or CR by RECIST v1.1 criteria) lasting > 6 months
  • Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.

Exclusion Criteria:

  • Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:

    • Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment
    • Any chemotherapy < 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.
    • Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment
  • Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Bosnia and Herzegovina,   Czechia,   Hungary,   Lithuania,   Russian Federation,   Serbia,   Ukraine,   United States
Removed Location Countries Bulgaria,   Georgia,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03560531
Other Study ID Numbers  ICMJE ZN-c5-001
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Zeno Alpha Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zeno Alpha Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zeno Alpha, Inc. Zeno Alpha Inc.
PRS Account Zeno Alpha Inc.
Verification Date February 2023

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