Trials / Completed
CompletedNCT01964430
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 866 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
Detailed description
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Conditions
- Pancreatic Neoplasms
- Digestive System Neoplasms
- Neoplasms by Site
- Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Digestive System Diseases
- Endocrine System Diseases
- Gemcitabine
- Antimetabolites, Antineoplastic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-Paclitaxel | nab-Paclitaxel 125 mg/m\^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles. |
| DRUG | Gemcitabine | Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles. |
Timeline
- Start date
- 2014-03-28
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2013-10-17
- Last updated
- 2023-06-28
- Results posted
- 2020-01-06
Locations
341 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01964430. Inclusion in this directory is not an endorsement.