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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01282333
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed advanced biliary/pancreatic cancer, urothelial cancer, or non-small cell lung cancer that is metastatic or unresectable
* Patients with known CNS metastases should be excluded from this clinical trial
* ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
* Life expectancy of greater than 12 weeks
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin within normal institutional limits
* AST/ALT ≤ 2.5 times institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min
* QTc interval on ECG ≤ 0.48 seconds by Bazett's calculation (≤ CTCAE v.4 grade 2)
* Not pregnant or nursing
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* Patients must be able to swallow pills and have no significant impairment in gastrointestinal absorption
* Patients with known or suspected germline mutation in BRCA1 or BRCA2 are eligible to participate
* Patients in study screening (primarily those with pancreatic cancer) who have a family history that is suspicious for BRCA1 or BRCA2 germline mutation should be assessed by the BRCAPRO computer program to quantitate the likelihood of harboring a deleterious BRCA mutation
* Patients found to have a BRCAPRO probability score of ≥ 20% should undergo formal full-sequence BRCA testing
* Patients in screening with a BRCAPRO probability of ≥ 20% who decline genetic testing are not eligible to participate in this trial due to the potential to confound safety assessment
* No uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* HIV-positive patients are eligible
* No active seizure or history of seizure disorder
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or other agents used in this study
* No peripheral neuropathy greater than grade1
* No prior systemic treatment
* No prior cytotoxic chemotherapy (neoadjuvant, adjuvant, or metastatic setting)
* At least 4 weeks since major surgery or radiation therapy
* Patients may not be receiving any other investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01282333
Study Brief:
Protocol Section:
NCT01282333