Clinical trialPhase 2Unknown
Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 1 March 2019
- Expected end
- 31 December 2021
- Enrollment
- 120 participants
- Sites
- 1
- Primary outcomes
- Overall Response Rate; Progression Free Survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 26 April 2019
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Brief summary public domain (ClinicalTrials.gov)
This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) and gemcitabine 1000 mg/m\^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.