Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC) (NCT04046887) | Clinical Trial Compass
TerminatedPhase 1
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Stopped: Unable to proceed due to Neulasta difficulties and other complications.
United States14 participantsStarted 2019-09-11
Plain-language summary
The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. ā„ 18 years old at the time of informed consent
ā. Ability to provide written informed consent and HIPAA authorization
ā. Untreated locally advanced Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion)
ā. Histologically or cytologically confirmed PDAC
ā. Confirmed PDAC that is measurable or evaluable per RECIST 1.1
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
ā. Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less
ā. Adequate organ function as defined by:
Exclusion criteria
ā. Neuropathy \> Grade 1 at baseline
ā. Prior systemic chemotherapy for any other malignancy (aside from adjuvant therapy for PDAC) in the last 3 years
ā. Active malignancy other than PDAC (other than adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated \>3 years prior to entry with no clinical evidence of recurrence is permitted)
ā. Major surgery, other than diagnostic or laparoscopic surgery, within 4 weeks prior to first dose. (Port placement would not be considered a surgery.)
ā. Any known untreated brain metastases including leptomeningeal metastases