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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (approximately 2 years)
Awards & highlights
Study Summary
This trial will test a new drug, ZN-c5, to treat advanced breast cancer that is positive for estrogen receptors and negative for human epidermal growth factor receptor 2. The drug will be given orally, and the trial will assess safety, tolerability, and preliminary efficacy.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (approximately 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy
Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 when administered in combination with palbociclib
Phase 1 EXP: Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events
+2 moreSecondary outcome measures
Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events
Safety and tolerability of ZN-c5 in combination with palbociclib as measured by number of treatment emergent adverse events
Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Arthralgia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Skin infection
7%
Blurred vision
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Itchy skin
6%
Death
6%
Dehydration
6%
Cellulitis
6%
Knee pain
6%
Cataract
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Memory impairment
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Edema trunk
4%
Sinus pain
4%
Back spasms
4%
Watering eyes
4%
Dry eye
4%
Head injury
4%
Burn
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Hoarseness
2%
Urine discoloration
2%
Lung cancer
2%
COPD
2%
Oral fissure
2%
Cold sweats
2%
Intrascapular pain
2%
Eye lid pain
2%
Paronychia
2%
Vaginal itching
2%
Sinus congestion
2%
Pharyngitis
2%
Yeast infection
2%
Puncture wound
2%
Vaginal infection
2%
Activated partial thromboplastin time prolonged
2%
Shoulder nodule
2%
Blood bilirubin increased
2%
Hypermagnesemia
2%
Bladder infection
2%
Diverticulitis
2%
Flank pain
2%
Paresthesia
2%
Cognitive disturbance
2%
Sinus tachycardia
2%
Localized edema
2%
Wrist pain
2%
Fever blister
2%
Radiation recall reaction (dermatologic)
2%
Facial nerve disorder
2%
Agitation
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Photophobia
2%
Hemorrhoids
2%
Sepsis
2%
Fracture
2%
Vaginal discharge
2%
Generalized weakness
2%
Leg pain
2%
Wrist fracture
2%
Bilateral nares sores
2%
Rhinovirus
2%
Laryngeal inflammation
2%
Erythema right breast
2%
Wound infection
2%
Hyperuricemia
2%
Urinary retention
2%
Erythema multiforme
2%
Nail loss
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
Trial Design
2Treatment groups
Experimental Treatment
Group I: ZN-c5 monotherapyExperimental Treatment1 Intervention
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.
Group II: ZN-c5 + palbociclib combination therapyExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZN-c5
2020
Completed Phase 2
~270
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Zeno Alpha Inc.Lead Sponsor
3 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
Carrie Brownstein, MDStudy ChairZeno Alpha Inc.
1 Previous Clinical Trials
14 Total Patients Enrolled
1 Trials studying Breast Cancer
14 Patients Enrolled for Breast Cancer
Mieke Ptaszynski, MDStudy DirectorZeno Alpha Inc.
2 Previous Clinical Trials
49 Total Patients Enrolled
2 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for participants in this trial?
"At this moment, recruitment for this trial is not available. Initially listed on December 8th 2018 and last revised November 2nd 2022, the research is currently at a standstill. For those seeking to participate in other studies, there are 2596 trials related to breast cancer that still need participants as well as 133 further investigations concerning ZN-c5."
Answered by AI
What other experiments have been conducted using ZN-c5 as a variable?
"Presently, there are 133 trials being conducted for ZN-c5. Of these active clinical studies, 16 have already advanced to Phase 3 status. Although the majority of all related tests originate from Burgas in New jersey, over 6500 other sites around the world offer patients access to this specific treatment regimen."
Answered by AI
To what ailments is ZN-c5 most often administered?
"ZN-c5 has been found to be effective in treating a variety of maladies, such as postmenopause and advance directives. The drug is most commonly prescribed for the treatment of breast cancer."
Answered by AI
Is there an opportunity to join this experiment at present?
"At the present moment, this specific trial has ceased searching for patients. Initially posted on December 8th 2018, it was last updated November 2nd 2022. If seeking alternative clinical trials related to breast cancer, there are 2596 studies available and 133 recruiting individuals suffering from ZN-c5."
Answered by AI
Are multiple sites in North America carrying out this research?
"Currently, 12 different trial sites are enrolling patients in locales including New york City, Nashville, and Houston. It is advisable to pick the closest one to reduce any inconveniences related to travelling if you choose to take part."
Answered by AI
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