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A Study of ZN-c5 in Subjects With Breast Cancer

Sponsor
Zeno Alpha Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03560531
Collaborator
(none)
181
Enrollment
38
Locations
2
Arms
65.8
Anticipated Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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.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 :
Dec 8, 2018
Actual Primary Completion Date :
Apr 26, 2022
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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 Names:
  • IBRANCE®

    		•

    Outcome Measures

    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 [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 [9 months]

    3. Phase 1 EXP: Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events [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 [Through study completion (approximately 2 years)]

    5. Phase 2: Determine preliminary anti-tumor efficacy (CBR) for ZN-c5 when administered in combination with palbociclib [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 [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 [Through study completion (approximately 2 years)]

      Measured by the number of treatment-emergent adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Site 3 Tucson Arizona United States 85719
    2 Site 5 Los Angeles California United States 91010
    3 Site 48 Bethesda Maryland United States 20817
    4 Site 47 Saint Louis Missouri United States 63110
    5 Site 7 New York New York United States 10029
    6 Site 2 New York New York United States 10032
    7 Site 50 Charleston South Carolina United States 29414
    8 Site 4 Nashville Tennessee United States 37240
    9 Site 1 Houston Texas United States 77030
    10 Site 8 Houston Texas United States 77030
    11 Site 6 Seattle Washington United States 98195
    12 Site 46 Minsk Belarus 223040
    13 Site 45 Vitebsk Belarus 210603
    14 Site 10 Banja Luka Bosnia and Herzegovina 78000
    15 Site 9 Sarajevo Bosnia and Herzegovina 71000
    16 Site 11 Tuzla Bosnia and Herzegovina 75000
    17 Site 29 Brno Czechia 65653
    18 Site 28 Olomouc Czechia 77900
    19 Site 30 Praha 5 Czechia 15006
    20 Site 51 Budapest Hungary H-1062
    21 Site 35 Kecskemét Hungary H-6000
    22 Site 37 Pécs Hungary H-7624
    23 Site 17 Kaunas Lithuania 50161
    24 Site 16 Vilnius Lithuania 08660
    25 Site 42 Ekaterinburg Russian Federation 620036
    26 Site 40 Nizhniy Novgorod Russian Federation 603089
    27 Site 52 Omsk Russian Federation 644013
    28 Site 41 Pyatigorsk Russian Federation 357502
    29 Site 39 Saint Petersburg Russian Federation 197022
    30 Site 18 Belgrade Serbia 11000
    31 Site 19 Belgrade Serbia 11080
    32 Site 21 Niš Serbia 18000
    33 Site 20 Novi Sad Serbia 21204
    34 Site 25 Cherkasy Ukraine 18009
    35 Site 27 Kharkiv Ukraine 61070
    36 Site 24 Kropyvnytskyi Ukraine 25006
    37 Site 26 Kryvyi Rih Ukraine 50048
    38 Site 23 Kyiv Ukraine 03115

    Sponsors and Collaborators

    • Zeno Alpha Inc.

    Investigators

    • Study Director: Andrew Henry, Zeno Alpha Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeno Alpha Inc.
    ClinicalTrials.gov Identifier:
    NCT03560531
    Other Study ID Numbers:
    • ZN-c5-001
    First Posted:
    Jun 18, 2018
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    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:
    Breast Neoplasms
    Palbociclib

    Study Results

    No Results Posted as of Aug 15, 2022