Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) (apact)
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ClinicalTrials.gov Identifier: NCT01964430 |
Recruitment Status :
Completed
First Posted : October 17, 2013
Results First Posted : January 6, 2020
Last Update Posted : June 28, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Tracking Information | ||||
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First Submitted Date ICMJE | October 14, 2013 | |||
First Posted Date ICMJE | October 17, 2013 | |||
Results First Submitted Date ICMJE | December 17, 2019 | |||
Results First Posted Date ICMJE | January 6, 2020 | |||
Last Update Posted Date | June 28, 2023 | |||
Actual Study Start Date ICMJE | March 28, 2014 | |||
Actual Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee [ Time Frame: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone ] 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-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.
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Original Primary Outcome Measures ICMJE |
Disease Free Survival (DFS) [ Time Frame: up to approximately 9 months ] Time from the date of randomization to the date of disease recurrence or death, whichever is earlier. (Disease recurrence will be determined by independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans.)
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
866 | |||
Original Estimated Enrollment ICMJE |
800 | |||
Actual Study Completion Date ICMJE | June 30, 2022 | |||
Actual Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Portugal, Singapore, Spain, Taiwan, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01964430 | |||
Other Study ID Numbers ICMJE | ABI-007-PANC-003 2013-003398-91 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Celgene | |||
Original Responsible Party | Celgene Corporation | |||
Current Study Sponsor ICMJE | Celgene | |||
Original Study Sponsor ICMJE | Celgene Corporation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Celgene | |||
Verification Date | June 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |