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:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02940132
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Aged 18-70 years
* Dose escalation study: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists/Dose Expansion study: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists and negative expression of ATM or BRCA1 or BRCA2 mutation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Have measurable lesion exists(RECIST 1.1)
* Life expectancy≥3 months
* Have adequate bone marrow, hepatic and renal functions
Exclusion Criteria:
* Allergic constitution or hypersensitivity to investigational drugs or relevant drug
* Patients who received any previous treatment with a PARP inhibitor
* Patients accepted anti-cancer therapy including chemotherapy, radiotherapy, endocrinotherapy, immunotherapy, Chinese herbal treatment or other investigational drugs within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea)
* With serious pre-existing medical conditions, such as significant cardiovascular disease and psychogenic disorders
* With family history of long QT syndrome or QTc ≥ 450 ms
* With persistent CTCAE ≧grade 2 toxicities (excluding alopecia) caused by prior medication
* With symptomatic brain metastases
* Pregnancy or lactation
* With Hepatitis B or C or human immunodeficiency virus infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02940132
Study Brief:
Protocol Section:
NCT02940132