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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01822756
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years or older
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Requirements for prior therapy as outlined below:
* Enrollment into Regimen A: received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
* Enrollment into Regimen B: received no prior chemotherapy for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
* Adequate renal, hepatic, and bone marrow function without blood product or hematopoietic growth factor support:
* Able to swallow and retain oral medication
Exclusion Criteria:
* Any known contraindications to the use of gemcitabine (for enrollment in Regimen A or B) or nab-paclitaxel (for enrollment into Regimen B).
* Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
* Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment. Subjects who have received radiation to the spine, pelvis, ribs, or femur should be discussed with the sponsor, as extensive radiation to marrow forming region may compromise a subject's ability to tolerate myelosuppressive chemotherapy. Subjects who have ongoing radiotherapy-related toxicities are not eligible.
* Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
* Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or other noninvasive malignancy without sponsor approval.
* Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
* Recent (≤ 3 months) history of partial or complete bowel obstruction.
* Unwilling to be transfused with blood components.
* Known history of Hepatitis B or C infection or HIV infection.
* Presence of ≥ Grade 2 neuropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01822756
Study Brief:
Protocol Section:
NCT01822756