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Completed

NCT Number: NCT03560531

A Study of ZN-c5 in Subjects With Breast Cancer

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®).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site 46, Minsk, Belarus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females;
  • Documented bilateral oophorectomy; or 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 (stable disease, partial response, or complete response 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)

Treatment and study plan

ZN-c5

Drug

ZN-c5 is a study drug

Palbociclib

Drug

Palbociclib (IBRANCE®) is an approved drug

Other names: IBRANCE®

Primary outcomes

  1. Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy

    Time frame: 24 weeks

    CBR is defined as the number of participants who have at least 1 confirmed response of complete response (CR) or partial response (PR) (only if participant has measurable disease), or stable disease (SD) >= 24 weeks (or non-CR/non-progressive disease (PD) >=24 weeks for participants with non-measurable disease) prior to any evidence of progression.

  2. Best Overall Response (BOR) for ZN-c5 as a Monotherapy

    Time frame: 24 weeks

    Best overall response was summarized categorically based on the four RECIST categories: CR, PR, SD and PD.

Secondary outcomes

  1. Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months

    Time frame: 2 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  2. Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months

    Time frame: 4 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  3. Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months

    Time frame: 6 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  4. Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months

    Time frame: 8 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  5. Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months

    Time frame: 10 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  6. Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months

    Time frame: 12 months

    PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  7. Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months

    Time frame: 2 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  8. Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months

    Time frame: 4 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  9. Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months

    Time frame: 6 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  10. Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months

    Time frame: 8 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  11. Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months

    Time frame: 10 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  12. Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months

    Time frame: 12 months

    OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

  13. Objective Response Rate (ORR) for ZN-c5 as a Monotherapy

    Time frame: 24 weeks

    ORR is defined as the number of participants with measurable disease who have at least 1 confirmed response of CR or PR prior to any evidence of progression (as defined by RECIST v1.1).

Sponsors and collaborators

Lead sponsor

Zeno Alpha Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2018
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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