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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 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.

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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.

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

FieldValue
Enrollment Target 866 participants
Start Date 2014-03-28
Est. Completion 2022-06-30
Phase Phase 3

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT01964430

The ClinicalTrials.gov registry entry for NCT01964430 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 866 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (46% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.