EUCTR2018-001364-27-CZ进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female
- •2) Age = 18 years
- •3) Menopausal Status [Female subjects]:
- •Postmenopausal, as defined by at least one of the following
- •a) Age = 60 years;
- •b) 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;
- •c) Documented bilateral oophorectomy;
- •Pre- or peri-menopausal, who must receive a gonadotropin-releasing hormone agonist
- •beginning at least 4 weeks prior to first dose of study medication.
- •4) Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast, not
- •amenable to any potential curative intervention
- •5) Estrogen Receptor (ER) positive disease defined as follows documented by a local laboratory:
- •a) [Monotherapy Escalation and Combination Dose Escalation Cohorts]: > 1% positive stained cells
- •based on medical record, archival tumor biopsy, or de novo tumor biopsy
- •b) [Monotherapy Expansion/Monotherapy Phase 2/Combination Phase 2 Cohorts]: > 10% positive
- •stained cells
- •6) Human Epidermal Growth Factor Receptor 2 (HER2) negative disease as documented by a local
- •a) [Monotherapy Escalation and Combination Dose Escalation Cohorts]: Documentation by medical
- •record or archival tumor tissue allowed
- •b) [Monotherapy Expansion/Monotherapy Phase 2/Combination Phase 2 Cohorts]: Based on
- •analysis of archival tumor biopsy or de novo biopsy with HER2-negativity defined as: 1)
- •Immunohistochemistry score 0/1+ or 2) Negative by in situ hybridization (FISH/CISH/SISH)
- •defined as a HER2/CEP17 ratio < 2, or for single probe assessment a HER2 copy number < 4
- •7) [Monotherapy Escalation and Combination Dose Escalation Cohorts]: Refractory to or intolerant of
- •established therapy(ies) known to provide clinical benefit for their malignancy
- •8) Prior Hormonal Therapy:
- •a) [Monotherapy Expansion Cohort]: up to 2 prior lines of endocrine therapy for advanced or
- •metastatic breast cancer
- •b) [Monotherapy Phase 2]: 1 prior line of endocrine therapy for advanced or metastatic breast
- •c) [Combination Phase 2]: up to 1 prior line of endocrine therapy for advanced or metastatic
- •breast cancer
- •d) Subjects who will undergo a FES-PET must have discontinued all prior ER blocking therapy (e.g.,
- •tamoxifen or fulvestrant) for = 60 days before the day of the examination at baseline.
- •In counting lines of treatment for advanced/metastatic disease, any change in regimen due to PD or
- •toxicity will be counted as a separate line of treatment.
- •9) Documented prior response to endocrine therapy for advanced or metastatic disease (SD, PR, or CR)
- •lasting > 6 months or disease recurrence after at least 24 months of adjuvant endocrine treatment.
- •(not required for treatment naïve patients)
- •10) Prior Chemotherapy:
- •a) [Monotherapy Dose Escalation Cohort]: Up to 2 prior lines of chemotherapy for the treatment
- •of advanced breast cancer
- •b) [Monotherapy Phase 2]: No prior chemotherapeutic regimens for the treatment of advanced
- •breast cancer
- •c) [Monotherapy Expansion, Combination Dose Escalation and Combination Phase 2 Cohorts]: Up
- •to 1 prior line of chemotherapy for the treatment of advanced breast cancer
- •In counting lines of treatment for advanced/metastatic disease, any change in regimen due to PD or
- •toxicity will be counted as a separate line of treatment.
- •11) Prior treatment with a CDK4/6 inhibitor is allowed
- 另有 1 项未显示
排除标准
- •1) Any of the following within the specified window prior to the first dose of study drug:
- •a) Tamoxifen, AI, fulvestrant or other anti-cancer endocrine therapy < 14 days
- •b) Any chemotherapy < 28 days (or 5 half-lives, whichever is shorter)
- •c) Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
- •d) Prior radiotherapy < 14 days (except for palliative radiotherapy to peripheral sites without
- •residual toxicity)
- •e) Major surgery < 28 days
- •f) Minor surgery < 7 days (placement of central venous catheter, fine needle aspiration, or
- •endoscopic biliary stent < 1 day is acceptable)
- •2) Prior hematopoietic stem cell or bone marrow transplantation
- •3) Prior radiotherapy to > 25% of bone marrow
- •4) Brain metastases that require immediate treatment or are clinically or radiologically unstable (i.e.,
- •have been stable for < 1 month). If receiving steroids, subjects must be receiving a stable to
- •decreasing corticosteroid dose during at least 1 week before enrollment.
- •5) Leptomeningeal disease that requires or is anticipated to require immediate treatment.
- •6) Presence of life-threatening metastatic visceral disease or symptomatic pulmonary lymphangitic
- •7) Other known active cancer(s) likely to require treatment in the next year that would impact the
- •assessment of any study endpoints
- •8) [Female subjects]: Pregnant or breast-feeding
- •9) Unexplained symptomatic endometrial disorders (including, but not limited to endometrial
- •hyperplasia, dysfunctional uterine bleeding, or cysts)
- •10) Uncontrolled symptomatic thyroid dysfunction
- •11) Impairment of gastrointestinal (GI) absorption for oral medications
- •12) Nausea, vomiting, or diarrhea > Grade 1
- •13) Myocardial infarction, symptomatic congestive heart failure (NYHA > Class II), unstable angina, or
- •serious uncontrolled cardiac arrhythmia within the last 6 months
- •14) QTc interval > 480 msec (based on the mean value of the triplicate ECGs), family or personal history
- •of long or short QT syndrome, Brugada syndrome or history of Torsade de Pointes
- •15) Concurrent use of food or drugs known to be moderate or strong CYP3A or CYP2C9 inducers and
- •moderate or strong CYP3A4 or CYP2C9 inhibitors. In addition, for moderate or strong CYP3A or
- •CYP2C9 inducers, there should be a wash-out of 14 days (or 5 half-lives, whichever is shorter) before
- •the first administration of study drug (see Section 10.4.6).
- •16) Any clinically significant disorder, condition, or disease that, in the opinion of the Investigator or
- •Medical Monitor would pose a risk to subject safety or interfere with the study evaluations,
- •procedures, or completion
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