Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03944902
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Estimated life expectancy of at least 3 months
* Measurable disease; at least one tumor lesion/lymph node that meets the RECIST 1.1 criteria for measurability
* Negative serum or urine pregnancy test within 3 days prior to the first dose
* Serum creatinine \<= 2.0 x upper limit of normal (ULN)
* Adequate hematological function
* Alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) \<3.0 x ULN
* Total bilirubin \<=1.5 x ULN
Exclusion Criteria:
* Prior treatment with CB-839 or a PARP inhibitor
* Receipt of any anticancer therapy within the following windows:
* Small molecule tyrosine kinase inhibitor therapy (including investigational) within 2 weeks or 5 half-lives, whichever is longer
* Any type of anti-cancer antibody within 4 weeks
* Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization
* Subjects with clinically relevant ongoing complications from prior radiation therapy
* Other investigational therapy within 2 weeks or 5 half-lives, whichever is longer
* Any other current or previous malignancy within he past three years except:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Prostate cancer with stable prostate specific antigen (PSA) levels for \>3 years
* Other neoplasm that, in the opinion of the Principal Investigator, will not interfere with the study-specific endpoints
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03944902
Study Brief:
Protocol Section:
NCT03944902