Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT02383433|
Recruitment Status : Terminated
First Posted : March 9, 2015
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: Regorafenib Drug: Gemcitabine Hydrochloride||Phase 2|
I. To assess the efficacy (progression-free survival) of regorafenib and gemcitabine (gemcitabine hydrochloride) in previously treated patients with metastatic pancreatic cancer.
I. To assess the safety of regorafenib in combination with gemcitabine. II. To assess response rate (RR). III. To assess overall survival (OS).
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up to 30 days and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Second-Line Therapy With Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer|
|Actual Study Start Date :||June 14, 2016|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||May 10, 2018|
Experimental: Treatment (regorafenib, gemcitabine hydrochloride)
Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Gemcitabine Hydrochloride
- Progression-free Survival [ Time Frame: Up to 1 year from enrollment ]Time-to-event data will be summarized using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383433
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Davendra Sohal, MD, MPH||Case Comprehensive Cancer Center|
|Principal Investigator:||Jennifer Eads, MD||Case Comprehensive Cancer Center|