A Study of ZN-c5 in Participants With Breast Cancer

  • STATUS
    Recruiting
  • End date
    Apr 5, 2022
  • participants needed
    36
  • sponsor
    Zeno Alpha Inc.
Updated on 5 November 2020
Investigator
Zeno Pharmaceuticals
Primary Contact
Site 9 (1.3 mi away) Contact
+16 other location
estradiol
breast adenocarcinoma

Summary

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

Details
Treatment ZN-c5
Clinical Study IdentifierNCT04176757
SponsorZeno Alpha Inc.
Last Modified on5 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
Signed and dated ICF
Age 18 years of age, either gender
Females must 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 levels within the local laboratory's normal reference range for postmenopausal females
Documented bilateral oophorectomy
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate organ function defined as follows
Hematologic: Platelets 100 109/L; Hemoglobin 9.0 g/dL; Absolute neutrophil count 1.5 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)
Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)
5 upper limit of normal (ULN); Total or conjugated bilirubin 1.5 ULN
Renal: Serum creatinine 1.5 ULN or creatinine clearance (CrCl) 60 mL/min

Exclusion Criteria

Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.5.0 Grade > 1
Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
Uncontrolled inter-current illness
History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet