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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 : Active, not recruiting
First Posted : October 17, 2013
Results First Posted : January 6, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Interventions Drug: nab-Paclitaxel
Drug: Gemcitabine
Enrollment 866
Recruitment Details The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US.
Pre-assignment Details Participants were randomized using a stratified randomization with a 1:1 ratio to either nab-paclitaxel followed by gemcitabine, or gemcitabine alone. Stratification factors were tumor resection status (R0 versus R1), nodal status lymph node positive versus lymph node negative, and region [North America, Europe, and Australia versus Asia Pacific]).
Arm/Group Title Nab-Paclitaxel and Gemcitabine Gemcitabine
Hide Arm/Group Description Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death. Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Period Title: Overall Study
Started 432 434
Treated Population 429 423
Completed [1] 287 310
Not Completed 145 124
Reason Not Completed
Adverse Event             71             37
Withdrawal by Subject             36             27
Death             1             3
Protocol Deviation             0             1
Physician Decision             5             4
Disease Relapse             28             38
Miscellaneous             1             3
Randomized but not Treated             3             11
[1]
Participants who completed 6 cycles of treatment.
Arm/Group Title Nab-Paclitaxel and Gemcitabine Gemcitabine Total
Hide Arm/Group Description Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death. Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death. Total of all reporting groups
Overall Number of Baseline Participants 432 434 866
Hide Baseline Analysis Population Description
The Intent-to-treat (ITT) population consisted of all randomized participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments collected.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 432 participants 434 participants 866 participants
63.4  (9.58) 62.9  (8.84) 63.2  (9.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
Female
204
  47.2%
181
  41.7%
385
  44.5%
Male
228
  52.8%
253
  58.3%
481
  55.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
Hispanic or Latino
11
   2.5%
15
   3.5%
26
   3.0%
Not Hispanic or Latino
400
  92.6%
393
  90.6%
793
  91.6%
Unknown or Not Reported
21
   4.9%
26
   6.0%
47
   5.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
American Indian or Alaska Native
0
   0.0%
1
   0.2%
1
   0.1%
Asian
60
  13.9%
56
  12.9%
116
  13.4%
Black or African American
4
   0.9%
8
   1.8%
12
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.5%
2
   0.2%
White
333
  77.1%
339
  78.1%
672
  77.6%
Other
11
   2.5%
6
   1.4%
17
   2.0%
Not Collected or Reported
24
   5.6%
22
   5.1%
46
   5.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
North America
144
  33.3%
156
  35.9%
300
  34.6%
Europe
203
  47.0%
205
  47.2%
408
  47.1%
Australia
30
   6.9%
20
   4.6%
50
   5.8%
Asia Pacific
55
  12.7%
53
  12.2%
108
  12.5%
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  M²
Number Analyzed 432 participants 434 participants 866 participants
1.77  (0.226) 1.78  (0.221) 1.78  (0.224)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
0 = Fully Active
252
  58.3%
268
  61.8%
520
  60.0%
1 = Restricted but Ambulatory
180
  41.7%
166
  38.2%
346
  40.0%
2 = Ambulatory but Unable to Work
0
   0.0%
0
   0.0%
0
   0.0%
3 = Limited Self-care
0
   0.0%
0
   0.0%
0
   0.0%
4 = Completely Disabled
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead
Physician Assessment of Peripheral Neuropathy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
Grade 0
404
  93.5%
408
  94.0%
812
  93.8%
Grade 1
26
   6.0%
21
   4.8%
47
   5.4%
Grade 2
0
   0.0%
1
   0.2%
1
   0.1%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   0.5%
4
   0.9%
6
   0.7%
[1]
Measure Description: Physician assessment for grading of peripheral neuropathy in participants receiving chemotherapy according to National Cancer Institute Common Toxicity Criteria (NCICTC): - Grade 1 = Asymptomatic: loss of deep tendon reflexes or paresthesia; - Grade 2 = Moderate symptoms: limiting instrumental Activities of Daily Living (ADLs); - Grade 3 = Severe symptoms: limiting self-care ADL; assistance device indicated; - Grade 4 = Life-threatening consequences: urgent intervention indicated.
Time from Surgery to Randomization  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 432 participants 434 participants 866 participants
57.0
(23.0 to 90.0)
56.0
(17.0 to 88.0)
57.0
(17.0 to 90.0)
TNM Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
T1 = Tumor is 2 cm or smaller
16
   3.7%
13
   3.0%
29
   3.3%
T2 = Tumor is > 2 cm, but not larger than 5 cm
38
   8.8%
37
   8.5%
75
   8.7%
T3 = Tumor is larger than 5 cm
377
  87.3%
384
  88.5%
761
  87.9%
T4 = Tumor is any size, but has spread
1
   0.2%
0
   0.0%
1
   0.1%
[1]
Measure Description:

The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting.

In the TNM system:

The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor and the "T" followed by a number shows the size of the tumor.

The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.

Nodal Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
Lymph Node Positive (LN+)
311
  72.0%
312
  71.9%
623
  71.9%
Lymph Node Negative (LN-)
121
  28.0%
122
  28.1%
243
  28.1%
[1]
Measure Description: The nodal status refers to the N and includes the number of nearby lymph nodes that are positive or negative for cancer.
Resection Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 434 participants 866 participants
R0 (tumor-negative resection margin)
327
  75.7%
334
  77.0%
661
  76.3%
R1 (tumor- positive resection margin)
105
  24.3%
100
  23.0%
205
  23.7%
[1]
Measure Description: Resection status was based on investigational site data (pathology reports were collected, but central pathology review and/or standardization was not conducted).
1.Primary Outcome
Title Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population consisted of all randomized participants regardless of whether they received any investigational product (IP) or had any efficacy assessment collected.
Arm/Group Title Nab-Paclitaxel and Gemcitabine Gemcitabine
Hide Arm/Group Description:
Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Overall Number of Participants Analyzed 432 434
Median (95% Confidence Interval)
Unit of Measure: months
19.4
(16.62 to 21.91)
18.8
(13.83 to 20.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel and Gemcitabine, Gemcitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1824
Comments [Not Specified]
Method Log Rank
Comments Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.729 to 1.063
Estimation Comments Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).
2.Secondary Outcome
Title Kaplan Meier Estimate of Overall Survival (OS)
Hide Description Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.
Time Frame From randomization date up to data cut off date of 31 Dec 2018; median OS follow-up time for censored participants was 38.702 months for nab-Paclitaxel and gemcitabine and 37.979 months for gemcitabine alone
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population consisted of all randomized participants regardless of whether the participant received any IP or had any efficacy assessment collected.
Arm/Group Title Nab-Paclitaxel and Gemcitabine Gemcitabine
Hide Arm/Group Description:
Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Overall Number of Participants Analyzed 432 434
Median (95% Confidence Interval)
Unit of Measure: months
40.5 [1] 
(35.55 to NA)
36.2
(31.11 to 40.34)
[1]
NA: The upper limit was not estimated because there were not enough events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel and Gemcitabine, Gemcitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0450
Comments [Not Specified]
Method Log Rank
Comments Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.680 to 0.996
Estimation Comments Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE's)
Hide Description TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. "Related" TEAE refers to relation to study drug (IP).
Time Frame From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018. up to 57 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Population consisted of randomized participants who received at least one dose of study drug.
Arm/Group Title Nab-Paclitaxel and Gemcitabine Gemcitabine
Hide Arm/Group Description:
Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Overall Number of Participants Analyzed 429 423
Measure Type: Count of Participants
Unit of Measure: Participants
≥1 TEAE
429
 100.0%
417
  98.6%
≥1 Related TEAE
423
  98.6%
399
  94.3%
≥1 TEAE of Severity Grade 3 or Higher
371
  86.5%
286
  67.6%
≥ 1 Related TEAE of Severity Grade 3 or Higher
332
  77.4%
239
  56.5%
≥1 Serious TEAE
176
  41.0%
96
  22.7%
≥1 Serious Related TEAE
102
  23.8%
55
  13.0%
≥1 TEAE Leading to Withdrawal of IP
117
  27.3%
43
  10.2%
≥1 Related TEAE Leading to Withdrawal of IP
98
  22.8%
35
   8.3%
≥1 TEAE Lead Dose Reduction: nab-Paclitaxel or Gem
276
  64.3%
210
  49.6%
≥1 Related TEAE Dose Reduct: nab-Paclitaxel or Gem
270
  62.9%
205
  48.5%
TEAE Lead Dose Interruption nab-Paclitaxel or Gem
266
  62.0%
158
  37.4%
≥1 Related TEAE Dose Interruption to IP
221
  51.5%
125
  29.6%
TEAE Leading to Death
2
   0.5%
2
   0.5%
>=1 Related TEAE Leading to Death
2
   0.5%
2
   0.5%
Time Frame From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nab-Paclitaxel/Gemcitabine Gemcitabine
Hide Arm/Group Description Participants received nab-Paclitaxel 125 mg/m^2 administered as intravenous (IV) infusion over 30- to 40-minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30- to 40-minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death. Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
All-Cause Mortality
Nab-Paclitaxel/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   205/429 (47.79%)   218/423 (51.54%) 
Hide Serious Adverse Events
Nab-Paclitaxel/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   176/429 (41.03%)   96/423 (22.70%) 
Blood and lymphatic system disorders     
Anaemia  1  12/429 (2.80%)  6/423 (1.42%) 
Anaemia of malignant disease  1  1/429 (0.23%)  0/423 (0.00%) 
Disseminated intravascular coagulation  1  1/429 (0.23%)  0/423 (0.00%) 
Febrile neutropenia  1  16/429 (3.73%)  3/423 (0.71%) 
Haemolytic uraemic syndrome  1  1/429 (0.23%)  1/423 (0.24%) 
Leukopenia  1  1/429 (0.23%)  0/423 (0.00%) 
Neutropenia  1  5/429 (1.17%)  3/423 (0.71%) 
Pancytopenia  1  1/429 (0.23%)  1/423 (0.24%) 
Thrombocytopenia  1  5/429 (1.17%)  1/423 (0.24%) 
Thrombotic microangiopathy  1  1/429 (0.23%)  2/423 (0.47%) 
Thrombotic thrombocytopenic purpura  1  0/429 (0.00%)  2/423 (0.47%) 
Cardiac disorders     
Acute myocardial infarction  1  0/429 (0.00%)  1/423 (0.24%) 
Angina pectoris  1  1/429 (0.23%)  0/423 (0.00%) 
Angina unstable  1  1/429 (0.23%)  0/423 (0.00%) 
Atrial fibrillation  1  3/429 (0.70%)  2/423 (0.47%) 
Atrial thrombosis  1  0/429 (0.00%)  1/423 (0.24%) 
Atrioventricular block second degree  1  1/429 (0.23%)  0/423 (0.00%) 
Cardiac failure  1  1/429 (0.23%)  1/423 (0.24%) 
Cardiac failure congestive  1  0/429 (0.00%)  4/423 (0.95%) 
Left ventricular failure  1  0/429 (0.00%)  1/423 (0.24%) 
Mitral valve incompetence  1  1/429 (0.23%)  0/423 (0.00%) 
Myocardial infarction  1  0/429 (0.00%)  1/423 (0.24%) 
Palpitations  1  0/429 (0.00%)  1/423 (0.24%) 
Pericardial effusion  1  0/429 (0.00%)  2/423 (0.47%) 
Tachycardia  1  1/429 (0.23%)  2/423 (0.47%) 
Gastrointestinal disorders     
Abdominal distension  1  1/429 (0.23%)  0/423 (0.00%) 
Abdominal hernia  1  0/429 (0.00%)  1/423 (0.24%) 
Abdominal pain  1  7/429 (1.63%)  4/423 (0.95%) 
Anal incontinence  1  1/429 (0.23%)  0/423 (0.00%) 
Anastomotic ulcer perforation  1  1/429 (0.23%)  0/423 (0.00%) 
Ascites  1  0/429 (0.00%)  2/423 (0.47%) 
Colitis  1  4/429 (0.93%)  0/423 (0.00%) 
Diarrhoea  1  12/429 (2.80%)  0/423 (0.00%) 
Enteritis  1  1/429 (0.23%)  1/423 (0.24%) 
Gastric haemorrhage  1  1/429 (0.23%)  0/423 (0.00%) 
Gastrooesophageal reflux disease  1  0/429 (0.00%)  1/423 (0.24%) 
Haematochezia  1  1/429 (0.23%)  0/423 (0.00%) 
Haemorrhoidal haemorrhage  1  1/429 (0.23%)  0/423 (0.00%) 
Ileus  1  2/429 (0.47%)  0/423 (0.00%) 
Internal hernia  1  1/429 (0.23%)  0/423 (0.00%) 
Intestinal obstruction  1  3/429 (0.70%)  0/423 (0.00%) 
Intra-abdominal fluid collection  1  0/429 (0.00%)  1/423 (0.24%) 
Jejunal perforation  1  1/429 (0.23%)  1/423 (0.24%) 
Large intestinal obstruction  1  0/429 (0.00%)  1/423 (0.24%) 
Nausea  1  3/429 (0.70%)  0/423 (0.00%) 
Obstruction gastric  1  0/429 (0.00%)  3/423 (0.71%) 
Oesophageal haemorrhage  1  0/429 (0.00%)  1/423 (0.24%) 
Pancreatic pseudocyst  1  2/429 (0.47%)  1/423 (0.24%) 
Pancreatitis  1  3/429 (0.70%)  1/423 (0.24%) 
Pancreatitis acute  1  1/429 (0.23%)  1/423 (0.24%) 
Small intestinal obstruction  1  2/429 (0.47%)  1/423 (0.24%) 
Stomatitis  1  2/429 (0.47%)  0/423 (0.00%) 
Vomiting  1  8/429 (1.86%)  0/423 (0.00%) 
General disorders     
Asthenia  1  3/429 (0.70%)  1/423 (0.24%) 
Chills  1  2/429 (0.47%)  2/423 (0.47%) 
Fatigue  1  7/429 (1.63%)  0/423 (0.00%) 
General physical health deterioration  1  2/429 (0.47%)  0/423 (0.00%) 
Generalised oedema  1  1/429 (0.23%)  3/423 (0.71%) 
Impaired healing  1  1/429 (0.23%)  0/423 (0.00%) 
Malaise  1  1/429 (0.23%)  1/423 (0.24%) 
Non-cardiac chest pain  1  0/429 (0.00%)  1/423 (0.24%) 
Oedema peripheral  1  4/429 (0.93%)  3/423 (0.71%) 
Peripheral swelling  1  0/429 (0.00%)  1/423 (0.24%) 
Pyrexia  1  29/429 (6.76%)  24/423 (5.67%) 
Systemic inflammatory response syndrome  1  1/429 (0.23%)  3/423 (0.71%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/429 (0.23%)  0/423 (0.00%) 
Bile duct stenosis  1  0/429 (0.00%)  1/423 (0.24%) 
Cholangitis  1  4/429 (0.93%)  3/423 (0.71%) 
Cholangitis acute  1  2/429 (0.47%)  0/423 (0.00%) 
Drug-induced liver injury  1  0/429 (0.00%)  1/423 (0.24%) 
Hepatic failure  1  0/429 (0.00%)  1/423 (0.24%) 
Hepatic function abnormal  1  1/429 (0.23%)  0/423 (0.00%) 
Hyperbilirubinaemia  1  0/429 (0.00%)  1/423 (0.24%) 
Hypertransaminasaemia  1  1/429 (0.23%)  0/423 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/429 (0.23%)  0/423 (0.00%) 
Infections and infestations     
Abdominal abscess  1  2/429 (0.47%)  0/423 (0.00%) 
Abdominal infection  1  4/429 (0.93%)  0/423 (0.00%) 
Appendicitis  1  0/429 (0.00%)  1/423 (0.24%) 
Arthritis bacterial  1  1/429 (0.23%)  0/423 (0.00%) 
Bacteraemia  1  2/429 (0.47%)  0/423 (0.00%) 
Biliary tract infection  1  1/429 (0.23%)  0/423 (0.00%) 
Bronchitis  1  1/429 (0.23%)  0/423 (0.00%) 
Catheter site infection  1  1/429 (0.23%)  0/423 (0.00%) 
Cellulitis  1  8/429 (1.86%)  5/423 (1.18%) 
Cholera  1  1/429 (0.23%)  0/423 (0.00%) 
Clostridium difficile colitis  1  2/429 (0.47%)  0/423 (0.00%) 
Clostridium difficile infection  1  3/429 (0.70%)  0/423 (0.00%) 
Colonic abscess  1  1/429 (0.23%)  0/423 (0.00%) 
Corona virus infection  1  1/429 (0.23%)  0/423 (0.00%) 
Cystitis  1  0/429 (0.00%)  2/423 (0.47%) 
Device related infection  1  4/429 (0.93%)  0/423 (0.00%) 
Device related sepsis  1  1/429 (0.23%)  0/423 (0.00%) 
Diverticulitis  1  0/429 (0.00%)  1/423 (0.24%) 
Enterocolitis infectious  1  1/429 (0.23%)  0/423 (0.00%) 
Erysipelas  1  0/429 (0.00%)  1/423 (0.24%) 
Escherichia sepsis  1  1/429 (0.23%)  0/423 (0.00%) 
Febrile infection  1  1/429 (0.23%)  0/423 (0.00%) 
Gastroenteritis clostridial  1  1/429 (0.23%)  0/423 (0.00%) 
Gastrointestinal infection  1  0/429 (0.00%)  1/423 (0.24%) 
Herpes zoster  1  1/429 (0.23%)  0/423 (0.00%) 
Infection  1  9/429 (2.10%)  1/423 (0.24%) 
Infectious colitis  1  1/429 (0.23%)  0/423 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/429 (0.23%)  1/423 (0.24%) 
Influenza  1  0/429 (0.00%)  1/423 (0.24%) 
Klebsiella bacteraemia  1  1/429 (0.23%)  0/423 (0.00%) 
Klebsiella infection  1  1/429 (0.23%)  0/423 (0.00%) 
Klebsiella sepsis  1  1/429 (0.23%)  0/423 (0.00%) 
Liver abscess  1  2/429 (0.47%)  0/423 (0.00%) 
Lung infection  1  2/429 (0.47%)  0/423 (0.00%) 
Neutropenic sepsis  1  2/429 (0.47%)  0/423 (0.00%) 
Pancreatic abscess  1  1/429 (0.23%)  0/423 (0.00%) 
Periodontitis  1  1/429 (0.23%)  0/423 (0.00%) 
Peritonitis  1  1/429 (0.23%)  1/423 (0.24%) 
Pneumonia  1  9/429 (2.10%)  6/423 (1.42%) 
Post procedural infection  1  1/429 (0.23%)  0/423 (0.00%) 
Postoperative abscess  1  1/429 (0.23%)  0/423 (0.00%) 
Respiratory syncytial virus infection  1  1/429 (0.23%)  0/423 (0.00%) 
Respiratory tract infection  1  1/429 (0.23%)  0/423 (0.00%) 
Sepsis  1  11/429 (2.56%)  5/423 (1.18%) 
Septic shock  1  1/429 (0.23%)  0/423 (0.00%) 
Subcutaneous abscess  1  1/429 (0.23%)  0/423 (0.00%) 
Tooth infection  1  0/429 (0.00%)  1/423 (0.24%) 
Urinary tract infection  1  7/429 (1.63%)  2/423 (0.47%) 
Urinary tract infection enterococcal  1  1/429 (0.23%)  0/423 (0.00%) 
Urosepsis  1  3/429 (0.70%)  0/423 (0.00%) 
Viral infection  1  2/429 (0.47%)  0/423 (0.00%) 
Viral upper respiratory tract infection  1  1/429 (0.23%)  0/423 (0.00%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/429 (0.23%)  0/423 (0.00%) 
Fall  1  1/429 (0.23%)  0/423 (0.00%) 
Femoral neck fracture  1  0/429 (0.00%)  1/423 (0.24%) 
Head injury  1  1/429 (0.23%)  0/423 (0.00%) 
Incisional hernia  1  0/429 (0.00%)  1/423 (0.24%) 
Patella fracture  1  1/429 (0.23%)  0/423 (0.00%) 
Peripancreatic fluid collection  1  1/429 (0.23%)  0/423 (0.00%) 
Post procedural fistula  1  1/429 (0.23%)  0/423 (0.00%) 
Post procedural inflammation  1  1/429 (0.23%)  0/423 (0.00%) 
Rib fracture  1  1/429 (0.23%)  0/423 (0.00%) 
Synovial rupture  1  1/429 (0.23%)  0/423 (0.00%) 
Toxicity to various agents  1  1/429 (0.23%)  2/423 (0.47%) 
Transfusion-related circulatory overload  1  0/429 (0.00%)  1/423 (0.24%) 
Traumatic fracture  1  1/429 (0.23%)  0/423 (0.00%) 
Wound secretion  1  1/429 (0.23%)  0/423 (0.00%) 
Investigations     
Blood alkaline phosphatase increased  1  1/429 (0.23%)  0/423 (0.00%) 
C-reactive protein increased  1  1/429 (0.23%)  0/423 (0.00%) 
Electrocardiogram ST segment elevation  1  0/429 (0.00%)  1/423 (0.24%) 
Electrocardiogram T wave inversion  1  0/429 (0.00%)  1/423 (0.24%) 
Electrocardiogram repolarisation abnormality  1  0/429 (0.00%)  1/423 (0.24%) 
Liver function test increased  1  1/429 (0.23%)  0/423 (0.00%) 
Neutrophil count decreased  1  1/429 (0.23%)  0/423 (0.00%) 
Transaminases increased  1  0/429 (0.00%)  1/423 (0.24%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/429 (0.23%)  0/423 (0.00%) 
Dehydration  1  8/429 (1.86%)  2/423 (0.47%) 
Diabetes mellitus  1  1/429 (0.23%)  1/423 (0.24%) 
Diabetes mellitus inadequate control  1  1/429 (0.23%)  0/423 (0.00%) 
Diabetic ketoacidosis  1  1/429 (0.23%)  0/423 (0.00%) 
Failure to thrive  1  1/429 (0.23%)  0/423 (0.00%) 
Fluid retention  1  1/429 (0.23%)  1/423 (0.24%) 
Hyperglycaemia  1  3/429 (0.70%)  1/423 (0.24%) 
Hyperkalaemia  1  1/429 (0.23%)  2/423 (0.47%) 
Hypoalbuminaemia  1  1/429 (0.23%)  0/423 (0.00%) 
Hypoglycaemia  1  2/429 (0.47%)  0/423 (0.00%) 
Hyponatraemia  1  1/429 (0.23%)  0/423 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle atrophy  1  1/429 (0.23%)  0/423 (0.00%) 
Myositis  1  1/429 (0.23%)  0/423 (0.00%) 
Osteoarthritis  1  0/429 (0.00%)  1/423 (0.24%) 
Pain in extremity  1  0/429 (0.00%)  1/423 (0.24%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma  1  1/429 (0.23%)  0/423 (0.00%) 
Colon cancer  1  0/429 (0.00%)  1/423 (0.24%) 
Tumour inflammation  1  1/429 (0.23%)  0/423 (0.00%) 
Nervous system disorders     
Dizziness  1  2/429 (0.47%)  1/423 (0.24%) 
Haemorrhage intracranial  1  1/429 (0.23%)  0/423 (0.00%) 
Headache  1  1/429 (0.23%)  0/423 (0.00%) 
Neuropathy peripheral  1  1/429 (0.23%)  0/423 (0.00%) 
Peripheral motor neuropathy  1  1/429 (0.23%)  0/423 (0.00%) 
Peroneal nerve palsy  1  2/429 (0.47%)  0/423 (0.00%) 
Syncope  1  4/429 (0.93%)  1/423 (0.24%) 
Product Issues     
Device occlusion  1  1/429 (0.23%)  0/423 (0.00%) 
Psychiatric disorders     
Confusional state  1  2/429 (0.47%)  0/423 (0.00%) 
Delirium  1  1/429 (0.23%)  0/423 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  2/429 (0.47%)  2/423 (0.47%) 
Nephrolithiasis  1  1/429 (0.23%)  0/423 (0.00%) 
Proteinuria  1  0/429 (0.00%)  1/423 (0.24%) 
Renal failure  1  1/429 (0.23%)  1/423 (0.24%) 
Urinary retention  1  1/429 (0.23%)  0/423 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/429 (0.23%)  0/423 (0.00%) 
Acute respiratory failure  1  1/429 (0.23%)  1/423 (0.24%) 
Alveolitis  1  1/429 (0.23%)  0/423 (0.00%) 
Aspiration  1  1/429 (0.23%)  0/423 (0.00%) 
Cough  1  1/429 (0.23%)  0/423 (0.00%) 
Dyspnoea  1  4/429 (0.93%)  4/423 (0.95%) 
Dyspnoea exertional  1  1/429 (0.23%)  0/423 (0.00%) 
Epistaxis  1  1/429 (0.23%)  0/423 (0.00%) 
Interstitial lung disease  1  1/429 (0.23%)  1/423 (0.24%) 
Non-cardiogenic pulmonary oedema  1  1/429 (0.23%)  0/423 (0.00%) 
Pleural effusion  1  0/429 (0.00%)  5/423 (1.18%) 
Pneumonitis  1  4/429 (0.93%)  2/423 (0.47%) 
Pneumothorax  1  1/429 (0.23%)  0/423 (0.00%) 
Pulmonary embolism  1  5/429 (1.17%)  3/423 (0.71%) 
Pulmonary oedema  1  1/429 (0.23%)  2/423 (0.47%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/429 (0.23%)  0/423 (0.00%) 
Vascular disorders     
Capillary leak syndrome  1  0/429 (0.00%)  1/423 (0.24%) 
Circulatory collapse  1  1/429 (0.23%)  0/423 (0.00%) 
Deep vein thrombosis  1  4/429 (0.93%)  1/423 (0.24%) 
Embolism  1  0/429 (0.00%)  2/423 (0.47%) 
Hypertension  1  2/429 (0.47%)  2/423 (0.47%) 
Hypotension  1  4/429 (0.93%)  3/423 (0.71%) 
Jugular vein thrombosis  1  0/429 (0.00%)  1/423 (0.24%) 
Subclavian vein thrombosis  1  1/429 (0.23%)  0/423 (0.00%) 
Thrombophlebitis  1  1/429 (0.23%)  0/423 (0.00%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nab-Paclitaxel/Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   425/429 (99.07%)   406/423 (95.98%) 
Blood and lymphatic system disorders     
Anaemia  1  179/429 (41.72%)  142/423 (33.57%) 
Leukopenia  1  84/429 (19.58%)  72/423 (17.02%) 
Neutropenia  1  263/429 (61.31%)  230/423 (54.37%) 
Thrombocytopenia  1  94/429 (21.91%)  85/423 (20.09%) 
Gastrointestinal disorders     
Abdominal pain  1  119/429 (27.74%)  87/423 (20.57%) 
Abdominal pain upper  1  35/429 (8.16%)  40/423 (9.46%) 
Constipation  1  114/429 (26.57%)  89/423 (21.04%) 
Diarrhoea  1  242/429 (56.41%)  125/423 (29.55%) 
Dyspepsia  1  0/429 (0.00%)  24/423 (5.67%) 
Flatulence  1  23/429 (5.36%)  27/423 (6.38%) 
Nausea  1  231/429 (53.85%)  192/423 (45.39%) 
Stomatitis  1  81/429 (18.88%)  24/423 (5.67%) 
Vomiting  1  122/429 (28.44%)  77/423 (18.20%) 
General disorders     
Asthenia  1  94/429 (21.91%)  49/423 (11.58%) 
Chills  1  38/429 (8.86%)  23/423 (5.44%) 
Fatigue  1  232/429 (54.08%)  203/423 (47.99%) 
Influenza like illness  1  27/429 (6.29%)  25/423 (5.91%) 
Oedema peripheral  1  162/429 (37.76%)  107/423 (25.30%) 
Peripheral swelling  1  22/429 (5.13%)  0/423 (0.00%) 
Pyrexia  1  169/429 (39.39%)  115/423 (27.19%) 
Infections and infestations     
Urinary tract infection  1  29/429 (6.76%)  0/423 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  42/429 (9.79%)  33/423 (7.80%) 
Aspartate aminotransferase increased  1  31/429 (7.23%)  0/423 (0.00%) 
Blood alkaline phosphatase increased  1  23/429 (5.36%)  0/423 (0.00%) 
Neutrophil count decreased  1  23/429 (5.36%)  32/423 (7.57%) 
Weight decreased  1  52/429 (12.12%)  22/423 (5.20%) 
Metabolism and nutrition disorders     
Decreased appetite  1  142/429 (33.10%)  84/423 (19.86%) 
Dehydration  1  28/429 (6.53%)  0/423 (0.00%) 
Hyperglycaemia  1  34/429 (7.93%)  28/423 (6.62%) 
Hypokalaemia  1  53/429 (12.35%)  23/423 (5.44%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  68/429 (15.85%)  31/423 (7.33%) 
Back pain  1  41/429 (9.56%)  44/423 (10.40%) 
Bone pain  1  23/429 (5.36%)  0/423 (0.00%) 
Muscular weakness  1  25/429 (5.83%)  0/423 (0.00%) 
Myalgia  1  57/429 (13.29%)  29/423 (6.86%) 
Pain in extremity  1  45/429 (10.49%)  33/423 (7.80%) 
Nervous system disorders     
Dizziness  1  64/429 (14.92%)  34/423 (8.04%) 
Dysgeusia  1  86/429 (20.05%)  36/423 (8.51%) 
Headache  1  65/429 (15.15%)  66/423 (15.60%) 
Neuropathy peripheral  1  108/429 (25.17%)  26/423 (6.15%) 
Paraesthesia  1  39/429 (9.09%)  0/423 (0.00%) 
Peripheral sensory neuropathy  1  142/429 (33.10%)  0/423 (0.00%) 
Polyneuropathy  1  23/429 (5.36%)  0/423 (0.00%) 
Psychiatric disorders     
Anxiety  1  34/429 (7.93%)  38/423 (8.98%) 
Insomnia  1  64/429 (14.92%)  34/423 (8.04%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  61/429 (14.22%)  51/423 (12.06%) 
Dyspnoea  1  65/429 (15.15%)  50/423 (11.82%) 
Epistaxis  1  76/429 (17.72%)  0/423 (0.00%) 
Oropharyngeal pain  1  28/429 (6.53%)  0/423 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  252/429 (58.74%)  52/423 (12.29%) 
Pruritus  1  36/429 (8.39%)  0/423 (0.00%) 
Rash  1  49/429 (11.42%)  0/423 (0.00%) 
Rash maculo-papular  1  35/429 (8.16%)  0/423 (0.00%) 
Vascular disorders     
Hypertension  1  35/429 (8.16%)  49/423 (11.58%) 
Hypotension  1  30/429 (6.99%)  0/423 (0.00%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
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.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 888-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Publications:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01964430    
Other Study ID Numbers: ABI-007-PANC-003
2013-003398-91 ( EudraCT Number )
First Submitted: October 14, 2013
First Posted: October 17, 2013
Results First Submitted: December 17, 2019
Results First Posted: January 6, 2020
Last Update Posted: April 16, 2020