NCT01893801

Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA

A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Pancreatic Cancer Research Team · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).

Detailed description

This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy. Overall response rates as well as individual categories of response (complete response-CR, partial response-PR, stable disease-SD and progressive disease-PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS (overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE (v4.0, May 2009).

Conditions

• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
DRUG	Cisplatin	25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
DRUG	gemcitabine	1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-04-01
• Completion: 2017-10-01
• First posted: 2013-07-09
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

3 sites across 1 country: United States