NCT02301143

Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

Detailed description

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery. Safety assessments by laboratory testing and physical exams will be conducted through-out the study. Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months. Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	nab-Paclitaxel
DRUG	Gemcitabine
DRUG	Chemoradiation
DRUG	Capecitabine
PROCEDURE	Surgery	Surgical intervention

Timeline

• Start date: 2015-04-21
• Primary completion: 2017-11-21
• Completion: 2018-04-26
• First posted: 2014-11-25
• Last updated: 2019-03-20
• Results posted: 2019-01-08

Locations

42 sites across 5 countries: United States, Canada, France, Italy, Spain