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Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
NCT01964430 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01964430
The ClinicalTrials.gov registry entry for NCT01964430 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 866 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01964430 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01964430?
The interventions under investigation include: Gemcitabine (DRUG), nab-Paclitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01964430?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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