Clinical trialPhase 2Terminated
Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer
A Phase II Study of Second-Line Therapy With Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer
- Outcome
- Stopped earlyPI discretion based on low accrual (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 14 June 2016
- Expected end
- 10 May 2018
- Enrollment
- 2 participants
- Sites
- 1
- Primary outcomes
- Progression-free Survival
- Sponsor
- Other
- Results posted
- 2019-05-10
- Last update
- 23 October 2023
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Brief summary public domain (ClinicalTrials.gov)
This phase II trial studies how well regorafenib and gemcitabine hydrochloride work as second-line therapy (treatment given when initial treatment doesn't work) in treating patients with pancreatic cancer that has spread to other parts of the body. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving regorafenib together with gemcitabine hydrochloride may kill more tumor cells.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To assess the efficacy (progression-free survival) of regorafenib and gemcitabine (gemcitabine hydrochloride) in previously treated patients with metastatic pancreatic cancer. SECONDARY OBJECTIVES: I. To assess the safety of regorafenib in combination with gemcitabine. II. To assess response rate (RR). III. To assess overall survival (OS). OUTLINE: 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [Up to 1 year from enrollment].