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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
History of Changes
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For the KPS baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine

ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.

Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest
Gemcitabine

Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Total Total of all reporting groups

Baseline Measures
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine     Gemcitabine     Total  
Number of Participants  
[units: participants]
 		  431     430     861  
Age  
[units: years]
Mean ± Standard Deviation 		  61.4  ± 10.70     63.0  ± 9.27     62.2  ± 10.04  
Gender  
[units: participants]
 		     
Female     186     173     359  
Male     245     257     502  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     8     9     17  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     16     16     32  
White     378     375     753  
More than one race     25     26     51  
Unknown or Not Reported     3     4     7  
Karnofsky Performance Status (KPS) [1]
[units: participants]
 		     
100% = normal, no complaints, no signs of disease     69     69     138  
90% = normal activity, few symptoms of disease     179     199     378  
80% = normal activity, some symptoms of disease     149     128     277  
70% = caring for self, unable to work     30     33     63  
60% = needs help, can manage most tasks     2     0     2  
50% = needs help often and medical care     0     0     0  
40% = disabled; requires special care & assistance     0     0     0  
30% = severely disabled; death is imminent     0     0     0  
20% = hospitalized; requires supportive treatment     0     0     0  
10% = Moribund, fatal processes progressing fast     0     0     0  
0% = Dead     0     0     0  
Pancreatic Primary Tumor Location [2]
[units: participants]
 		     
Head     191     180     371  
Body     132     136     268  
Tail     105     110     215  
Unknown = not specified     3     4     7  
Number of Baseline Lesions (Target + Non-Target) [3]
[units: participants]
 		     
1     1     0     1  
2     32     25     57  
3     7     7     14  
4     37     43     80  
5     8     8     16  
>5     276     262     538  
[1] The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.
[2] Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.
[3] Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.



  Outcome Measures
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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. ]
  Show Outcome Measure 1

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. ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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Time Frame Day 1 up to 30 days after the last dose (a maximum of 666 days)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine 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 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)

Other Adverse Events
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine     Gemcitabine  
Total, other (not including serious) adverse events      
# participants affected / at risk     412/421 (97.86%)     392/402 (97.51%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     175/421 (41.57%)     131/402 (32.59%)  
Neutropenia † 1    
# participants affected / at risk     172/421 (40.86%)     122/402 (30.35%)  
Thrombocytopenia † 1    
# participants affected / at risk     127/421 (30.17%)     115/402 (28.61%)  
Leukopenia † 1    
# participants affected / at risk     58/421 (13.78%)     39/402 (9.70%)  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     223/421 (52.97%)     189/402 (47.01%)  
Diarrhoea † 1    
# participants affected / at risk     182/421 (43.23%)     94/402 (23.38%)  
Vomiting † 1    
# participants affected / at risk     145/421 (34.44%)     107/402 (26.62%)  
Constipation † 1    
# participants affected / at risk     122/421 (28.98%)     111/402 (27.61%)  
Abdominal Pain † 1    
# participants affected / at risk     92/421 (21.85%)     87/402 (21.64%)  
Abdominal pain upper † 1    
# participants affected / at risk     42/421 (9.98%)     28/402 (6.97%)  
Dyspepsia † 1    
# participants affected / at risk     34/421 (8.08%)     28/402 (6.97%)  
Stomatitis † 1    
# participants affected / at risk     31/421 (7.36%)     14/402 (3.48%)  
Abdominal distension † 1    
# participants affected / at risk     16/421 (3.80%)     29/402 (7.21%)  
Ascites † 1    
# participants affected / at risk     15/421 (3.56%)     26/402 (6.47%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     247/421 (58.67%)     183/402 (45.52%)  
Oedema peripheral † 1    
# participants affected / at risk     194/421 (46.08%)     123/402 (30.60%)  
Pyrexia † 1    
# participants affected / at risk     160/421 (38.00%)     111/402 (27.61%)  
Asthenia † 1    
# participants affected / at risk     77/421 (18.29%)     51/402 (12.69%)  
Chills † 1    
# participants affected / at risk     48/421 (11.40%)     34/402 (8.46%)  
Mucosal inflammation † 1    
# participants affected / at risk     42/421 (9.98%)     16/402 (3.98%)  
Pain † 1    
# participants affected / at risk     24/421 (5.70%)     8/402 (1.99%)  
Infections and infestations      
Urinary tract infection † 1    
# participants affected / at risk     37/421 (8.79%)     14/402 (3.48%)  
Oral candidiasis † 1    
# participants affected / at risk     33/421 (7.84%)     15/402 (3.73%)  
Cellulitis † 1    
# participants affected / at risk     25/421 (5.94%)     16/402 (3.98%)  
Investigations      
Weight decreased † 1    
# participants affected / at risk     57/421 (13.54%)     47/402 (11.69%)  
Alanine aminotransferase increased † 1    
# participants affected / at risk     45/421 (10.69%)     36/402 (8.96%)  
Haemoglobin decreased † 1    
# participants affected / at risk     41/421 (9.74%)     29/402 (7.21%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     38/421 (9.03%)     35/402 (8.71%)  
Platelet count decreased † 1    
# participants affected / at risk     33/421 (7.84%)     25/402 (6.22%)  
Neutrophil count decreased † 1    
# participants affected / at risk     26/421 (6.18%)     19/402 (4.73%)  
Blood alkaline phosphatase increased † 1    
# participants affected / at risk     21/421 (4.99%)     30/402 (7.46%)  
Metabolism and nutrition disorders      
Decreased appetite † 1    
# participants affected / at risk     149/421 (35.39%)     104/402 (25.87%)  
Dehydration † 1    
# participants affected / at risk     75/421 (17.81%)     33/402 (8.21%)  
Hypokalemia † 1    
# participants affected / at risk     50/421 (11.88%)     28/402 (6.97%)  
Hypoalbuminaemia † 1    
# participants affected / at risk     25/421 (5.94%)     18/402 (4.48%)  
Hyperglycaemia † 1    
# participants affected / at risk     22/421 (5.23%)     18/402 (4.48%)  
Musculoskeletal and connective tissue disorders      
Pain in extremity † 1    
# participants affected / at risk     48/421 (11.40%)     24/402 (5.97%)  
Arthralgia † 1    
# participants affected / at risk     46/421 (10.93%)     13/402 (3.23%)  
Myalgia † 1    
# participants affected / at risk     44/421 (10.45%)     15/402 (3.73%)  
Back Pain † 1    
# participants affected / at risk     41/421 (9.74%)     40/402 (9.95%)  
Bone pain † 1    
# participants affected / at risk     24/421 (5.70%)     8/402 (1.99%)  
Nervous system disorders      
Neuropathy peripheral † 1    
# participants affected / at risk     116/421 (27.55%)     11/402 (2.74%)  
Peripheral sensory neuropathy † 1    
# participants affected / at risk     107/421 (25.42%)     17/402 (4.23%)  
Dysgeusia † 1    
# participants affected / at risk     68/421 (16.15%)     33/402 (8.21%)  
Headache † 1    
# participants affected / at risk     60/421 (14.25%)     38/402 (9.45%)  
Dizziness † 1    
# participants affected / at risk     47/421 (11.16%)     34/402 (8.46%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     64/421 (15.20%)     46/402 (11.44%)  
Depression † 1    
# participants affected / at risk     50/421 (11.88%)     24/402 (5.97%)  
Anxiety † 1    
# participants affected / at risk     35/421 (8.31%)     43/402 (10.70%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     72/421 (17.10%)     30/402 (7.46%)  
Dyspnoea † 1    
# participants affected / at risk     71/421 (16.86%)     61/402 (15.17%)  
Epistaxis † 1    
# participants affected / at risk     64/421 (15.20%)     14/402 (3.48%)  
Dyspnoea exertional † 1    
# participants affected / at risk     24/421 (5.70%)     13/402 (3.23%)  
Skin and subcutaneous tissue disorders      
Alopecia † 1    
# participants affected / at risk     212/421 (50.36%)     21/402 (5.22%)  
Rash † 1    
# participants affected / at risk     117/421 (27.79%)     39/402 (9.70%)  
Pruritis † 1    
# participants affected / at risk     34/421 (8.08%)     20/402 (4.98%)  
Dry Skin † 1    
# participants affected / at risk     24/421 (5.70%)     9/402 (2.24%)  
Erythema † 1    
# participants affected / at risk     24/421 (5.70%)     13/402 (3.23%)  
Vascular disorders      
Hypotension † 1    
# participants affected / at risk     38/421 (9.03%)     26/402 (6.47%)  
Deep vein thrombosis † 1    
# participants affected / at risk     30/421 (7.13%)     22/402 (5.47%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.0



  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
No text entered.


  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