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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT02049593
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST, v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT may be =\< 5 x ULN
* Total serum bilirubin =\< 1.5 x ULN
* Calculated creatinine clearance of \>= 40 ml/min; as per Cockcroft-Gault formula
* Hemoglobin \>= 9.0 g/dL
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Able to take oral medications
* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
* Sexually active patients must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 30 days after the last dose of BMN 673
* Females of childbearing potential must have a negative serum pregnancy test at screening
Exclusion Criteria:
* Has not recovered (recovery is defined as National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE version (v)4.03\] grade =\< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion
* Prior treatment with a PARP inhibitor
* Prior allergic reaction or severe intolerance to either irinotecan or temozolomide
* History of central nervous system (CNS) metastasis that are untreated or not stable
* Any antitumor systemic cytotoxic therapies within 28 days prior to enrollment (6 weeks for nitrosoureas or mitomycin-C); prior high-dose chemotherapy with bone marrow or stem cell transplant is excluded
* Is known to have human immunodeficiency virus (HIV) or has active hepatitis C virus (HCV), or active hepatitis B virus (HBV)
* Has had major surgery within 28 days prior to enrollment
* Active gastrointestinal tract disease with malabsorption syndrome
* Requirement for IV alimentation
* Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
* Symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication (atrial fibrillation is permitted)
* Use of any investigational product or investigational medical device within 28 days prior to enrollment
* Concurrent disease or condition that would interfere with study participation or safety, such as:
* Active, clinically significant infection requiring the use of parenteral anti-microbial agents, or grade \> 2 by NCI CTCAE (v 4.03) within 14 days prior to enrollment
* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
* Non-healing wound, ulcer, or bone fracture
* Bone marrow disorder including myelodysplasia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02049593
Study Brief:
Protocol Section:
NCT02049593