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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT03925350
Eligibility Criteria:
Inclusion Criteria:
* Have genetic homologous recombination (HR) mutation/ alteration including ARID1A/B, ARID2, ATM, ATR, ATRX, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B
* Disease must have progressed on the standard systemic therapies or they could not have tolerated the standard therapies.
* ECOG PS \>/=1
* Have measurable metastatic disease according to RECIST 1.1
* Prior systemic cytotoxic therapy up to 1 regimens is allowed; There is no limit on the number of prior immunotherapy or targeted therapy regimens.
* All adverse events associated with prior treatment must have resolved to ≤ Grade 1 prior to day 1 of the study drug administration.
Exclusion Criteria:
* Previously treated with a PARP inhibitor
* Symptomatic brain metastasis or active brain lesions ≥6 mm size or those
* Require steroid treatment for brain lesions or leptomeningeal disease
* Systemic cancer therapy within 14 days prior to day 1 of the study drug administration
* Any major surgery ≤ 3 weeks of starting the study and patient must have recovered from any effects of any major surgery
* Investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational
* Prior radiotherapy encompassing \> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy
* Medical history of immunocompromised condition
* Systemic treatment of another type of cancer ≤ 2 years prior to registration
* Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03925350
Study Brief:
Protocol Section:
NCT03925350