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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT02651727
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Histologically or cytologically confirmed diagnosis of an advanced nonhematological malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not surgically resectable
* Eligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in 28-day cycles as standard therapy
* Evaluable or measurable disease, as assessed by RECIST v1.1
* ECOG performance status of ≤ 1
* Adequate renal function (creatinine ≤ 1.5×ULN \[upper limit of normal\]) or glomerular filtration rate of ≥ 60 mL/min
* Adequate hepatic function (total bilirubin ≤ 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ≤ 2.5×ULN, or ≤ 5×ULN if due to liver involvement by tumor; albumin ≥ 3 g/dL)
* Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100×109 cells/L; absolute neutrophil count \[ANC\] ≥ 1.5×109 cells/L without the use of hematopoietic growth factors)
* Corrected QT interval (QTc) \< 470 ms
* Willing and able to participate in the trial and comply with all trial requirements
Exclusion Criteria:
* Gastrointestinal (GI) condition that could interfere with the swallowing or absorption of study medication
* Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
* History of upper gastrointestinal bleeding, ulceration, or perforation within 6 months prior to the first dose of protocol therapy
* Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of protocol therapy.
* Part B only: Prior therapy (including investigational agents) for pancreatic cancer
* Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy
* Active treatment for a secondary malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02651727
Study Brief:
Protocol Section:
NCT02651727