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A Study of ZN-c5 in Subjects With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03560531
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

Brief Summary:
This is a Phase I, open-label, multicenter, sequential 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 who have progressed following endocrine therapy. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: In the monotherapy portion of the study, up to 4 sequential dose escalation cohorts are planned, followed by monotherapy dose expansion. After the monotherapy dose escalation and expansion cohorts are enrolled, the combination dose escalation and expansion portion of the study will begin.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I 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 Previously Treated Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
Actual Study Start Date : December 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: ZN-c5 monotherapy
Sequential dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5, followed by expansion cohorts at each dose level.
Drug: ZN-c5
ZN-c5 is a study drug

Experimental: ZN-c5 + palbociclib combination therapy
After the MTD/RP2D of ZN-c5 as monotherapy has been determined, the combination cohort dose escalation will begin enrollment.The expansion cohorts are planned at each dose level.
Drug: ZN-c5
ZN-c5 is a study drug

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




Primary Outcome Measures :
  1. Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy [ Time Frame: 9 months ]
  2. 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 ]

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



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 who are 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;
    • Medically confirmed ovarian failure.
  • 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
  • Radiographic documentation of disease progression on the last (most recent) treatment administered prior to enrolling in the study.
  • Documented prior response to endocrine therapy for metastatic disease (SD, PR, or CR by RECIST v1.1 criteria) lasting > 6 months
  • Measurable disease meeting the criteria specified 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.

(Note: subjects with bone-only metastatic cancer may be enrolled in the dose escalation portion of the study but must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by CT or MRI.)

Exclusion Criteria:

  • Subjects who have received only neoadjuvant or adjuvant therapy for breast adenocarcinoma
  • Monotherapy: Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:

    • Tamoxifen, aromatase inhibitor, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment
    • Any chemotherapy < 28 days before first dose of study
    • Any investigational drug therapy < 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
  • Combination Therapy: Any prior treatment with any CDK4/6 inhibitor (combination cohorts only)
  • Any prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab)
  • Patients with bone-only disease (Dose Expansion cohorts only) Note: Patients with bone-only disease may be enrolled in the Dose Escalation portion of the study, but must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by CT or MRI
  • Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)

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


Contacts
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Contact: Zeno Alpha 858-263-4333 info@zenopharma.com

Locations
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United States, Arizona
Site 3 Recruiting
Tucson, Arizona, United States, 85719
United States, California
Site 5 Recruiting
Los Angeles, California, United States, 91010
United States, New York
Site 2 Recruiting
New York, New York, United States, 10032
United States, Tennessee
Site 4 Recruiting
Nashville, Tennessee, United States, 37240
United States, Texas
Site 1 Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Zeno Alpha Inc.
Investigators
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Study Director: Patrick Chun, MD Zeno Alpha Inc.

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Responsible Party: Zeno Alpha Inc.
ClinicalTrials.gov Identifier: NCT03560531     History of Changes
Other Study ID Numbers: ZN-c5-001
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Palbociclib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action