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Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00844649
First received: February 13, 2009
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: October 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Cancer
Interventions: Drug: Albumin-bound paclitaxel
Drug: Gemcitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem) Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine (Gem) Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

Participant Flow:   Overall Study
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)     Gemcitabine (Gem)  
STARTED     431 [1]   430 [1]
Treated Population     421 [2]   402 [2]
COMPLETED     26 [3]   12 [3]
NOT COMPLETED     405     418  
Progressive Disease                 196                 245  
Adverse Event                 128                 73  
Physician Decision                 25                 18  
Protocol Violation                 10                 6  
Withdrawal by Subject                 28                 39  
Unspecified                 7                 10  
Withdrew prior to starting treatment                 11                 27  
[1] Started = Intent to Treat Population and includes all randomized participants
[2] Treated population = all randomized patients who received at least one dose of study drug
[3] Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. ]

2.  Secondary:   Progression-free Survival (PFS) by Independent Radiological Review (IRR)   [ Time Frame: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. ]

3.  Secondary:   Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)   [ Time Frame: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months ]

4.  Other Pre-specified:   Participants With Treatment Emergent Adverse Events (AE)   [ Time Frame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days ]

5.  Other Pre-specified:   Number of Participants With Dose Reductions   [ Time Frame: Maximum time on treatment was 666 days ]

6.  Other Pre-specified:   Number of Participants With Dose Interruptions   [ Time Frame: Maximum time on treatment was 666 days ]

7.  Other Pre-specified:   Number of Participants With Dose Delays/Doses Not Given   [ Time Frame: Up to 666 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


No publications provided by Celgene Corporation

Publications automatically indexed to this study:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00844649     History of Changes
Other Study ID Numbers: CA046
Study First Received: February 13, 2009
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Italy: The Italian Medicines Agency
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Australia: Department of Health and Ageing Therapeutic Goods Administration