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A Study of ZN-c5 in Subjects With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03560531
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

Study Description
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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®).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ZN-c5 Drug: Palbociclib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
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
Official Title: 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
Actual Study Start Date : December 8, 2018
Actual Primary Completion Date : April 26, 2022
Actual Study Completion Date : December 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: ZN-c5
ZN-c5 is a study drug
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.
 Drug: ZN-c5
ZN-c5 is a study drug

Drug: Palbociclib
Palbociclib (IBRANCE®) is an approved drug
Other Name: IBRANCE®


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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

  4. 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) ]
  5. 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) ]

Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560531


Locations
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Sponsors and Collaborators
Zeno Alpha Inc.
Investigators
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Study Director: Zeno Alpha, Inc. Zeno Alpha Inc.
More Information
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Responsible Party: Zeno Alpha Inc.
ClinicalTrials.gov Identifier: NCT03560531    
Other Study ID Numbers: ZN-c5-001
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zeno Alpha Inc.:
Estrogen receptor
Hormone receptor
Selective estrogen receptor degrader
Hormone sensitive
 Phase 1 Dose Escalation
Phase 2 Combination
Phase 1 Dose Expansion
Phase 2 Monotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action