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NCT01964430 · ClinicalTrials.gov registry record · Phase 3
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
A Phase 3 study of Neoplasms and Pancreatic Neoplasms, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 866
- Enrollment target
- 20
- Study locations
NCT01964430: Completed Phase 3 study of Neoplasms and Pancreatic Neoplasms, sponsored by Celgene.
NCT01964430 is a Phase 3 study of Neoplasms and Pancreatic Neoplasms that has completed, run by Celgene. The registered enrollment target is 866 participants, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01964430, a Phase 3 study of Neoplasms and Pancreatic Neoplasms, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 866 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-fr
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG nab-Paclitaxel
Study Locations (20)
California
- UCSD Moores Cancer Center - La Jolla
- University of Southern California - Los Angeles
- Local Institution - 044 - Sacramento
- UC Davis Cancer Center - Sacramento
- Local Institution - 001 - San Francisco
- University of California, San Francisco Cutaneous Oncology and Melanoma Center - San Francisco
- University of California Los Angeles - Santa Monica
Florida
- Local Institution - 022 - Boca Raton
- Lynn Cancer Institute - Boca Raton
- Florida Cancer Institute Cancer Spec - Fort Myers
- Local Institution - 031 - Fort Myers
- Gainesville Heme Oncology Associates - Gainesville
- Local Institution - 011 - Gainesville
- University of Florida - Gainesville
Colorado
- University of Colorado Cancer Center - Aurora
- Local Institution - 059 - Denver
- Rocky Mountain Cancer Centers, LLP [Denver-Midtown] - Denver
Arizona
- Local Institution - 043 - Scottsdale
- Mayo Clinic - Arizona - Scottsdale
Connecticut
- Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 866 participants |
| Start Date | 2014-03-28 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 3 |
What the finished NCT01964430 record still lists
NCT01964430 is an interventional study that assigns participants to a tested intervention. The registered 866 participants enrollment target is mid-sized for trials with a published cap, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (46% lower).
The record links to 10 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01964430 names 20 study sites across 5 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01964430 about?
NCT01964430 is a clinical study titled "Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)". 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.
What is the current status of trial NCT01964430?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 866 participants. The study started on 2014-03-28. Estimated completion is 2022-06-30.
What conditions does trial NCT01964430 study?
This clinical trial studies the following conditions: Neoplasms, Pancreatic Neoplasms, Neoplasms by Site, Endocrine System Diseases, Pancreatic Diseases.
What interventions are being tested in trial NCT01964430?
The interventions under investigation include: Gemcitabine (DRUG), nab-Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01964430?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01964430 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01964430's enrollment target sits among peer trials
866 15th of 158 higher than 144 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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