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Breast CancerPhase 1/2NCT03560531

A Study of ZN-c5 in Subjects With Breast Cancer

A Phase 1/2 study testing ZN-c5 and Palbociclib in people with Breast Cancer, run by Zeno Alpha Inc. at 38 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
ZN-c5 and Palbociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
38 sitesin 9 countries
Study dates
30 Nov 2018to 22 Dec 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

38 sites in 9 countries.

38 sites in 9 countries

United States11 sites

  • Site 48

    Bethesda, Maryland, 20817

  • Site 50

    Charleston, South Carolina, 29414

  • Site 1

    Houston, Texas, 77030

  • Site 8

    Houston, Texas, 77030

  • Site 5

    Los Angeles, California, 91010

  • Site 4

    Nashville, Tennessee, 37240

  • Site 7

    New York, New York, 10029

  • Site 2

    New York, New York, 10032

  • Site 6

    Seattle, Washington, 98195

  • Site 47

    St Louis, Missouri, 63110

  • Site 3

    Tucson, Arizona, 85719

Other trials in United States

Russia5 sites

  • Site 40

    Nizhny Novgorod, 603089

  • Site 52

    Omsk, 644013

  • Site 41

    Pyatigorsk, 357502

  • Site 39

    Saint Petersburg, 197022

  • Site 42

    Yekaterinburg, 620036

Other trials in Russia

Ukraine5 sites

  • Site 25

    Cherkasy, 18009

  • Site 27

    Kharkiv, 61070

  • Site 24

    Kropyvnytskyi, 25006

  • Site 26

    Kryvyi Rih, 50048

  • Site 23

    Kyiv, 03115

Other trials in Ukraine

Serbia4 sites

  • Site 18

    Belgrade, 11000

  • Site 19

    Belgrade, 11080

  • Site 21

    Niš, 18000

  • Site 20

    Novi Sad, 21204

Other trials in Serbia

Bosnia and Herzegovina3 sites

  • Site 10

    Banja Luka, 78000

  • Site 9

    Sarajevo, 71000

  • Site 11

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Czechia3 sites

  • Site 29

    Brno, 65653

  • Site 28

    Olomouc, 77900

  • Site 30

    Prague, 15006

Other trials in Czechia

Hungary3 sites

  • Site 51

    Budapest, H-1062

  • Site 35

    Kecskemét, H-6000

  • Site 37

    Pécs, H-7624

Other trials in Hungary

Belarus2 sites

  • Site 46

    Minsk, 223040

  • Site 45

    Vitebsk, 210603

Other trials in Belarus

Lithuania2 sites

  • Site 17

    Kaunas, 50161

  • Site 16

    Vilnius, 08660

Other trials in Lithuania

About this study

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

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®).

Conditions
Breast Cancer
Being tested
ZN-c5, Palbociclib
Keywords
Estrogen receptor, Hormone receptor, Selective estrogen receptor degrader, Hormone sensitive, Phase 1 Dose Escalation, Phase 2 Combination, Phase 1 Dose Expansion, Phase 2 Monotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZN-c5Drug

    ZN-c5 is a study drug

  • PalbociclibDrug

    Also called IBRANCE®

    Palbociclib (IBRANCE®) is an approved drug

Study groups in NCT03560531
Study groupRoleWhat they receive
ZN-c5 monotherapyExperimentalDose 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.
Receives: Drug: ZN-c5
ZN-c5 + palbociclib combination therapyExperimentalDose 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.
Receives: Drug: ZN-c5; Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 24 weeks

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

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

    Measured: 24 weeks

Secondary outcomes (13)

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

    Measured: 2 months

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

    Measured: 4 months

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

    Measured: 6 months

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

    Measured: 8 months

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

    Measured: 10 months

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

    Measured: 12 months

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

    Measured: 2 months

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

    Measured: 4 months

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

    Measured: 6 months

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

    Measured: 8 months

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

    Measured: 10 months

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

    Measured: 12 months

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

    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).

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start30 Nov 2018
  3. Primary completion26 Apr 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560531
Sponsor's protocol ID
ZN-c5-001
Status last verified
Jul 2024
First submitted
5 Jun 2018
Last updated
9 Aug 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ZN-c5 and Palbociclib in people with Breast Cancer, run by Zeno Alpha Inc. at 38 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Russia, Ukraine, Serbia, Bosnia and Herzegovina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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