18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-limiting ToxicitiesPrimary· Cycle 1 (Days 1-28)
A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:
* Grade 4 neutropenia lasting \>3 days in the absence of growth factor support;
* Grade 4 neutropenia associated with fever \>38.5°C;
* Any other Grade 4 hematological toxicity;
* Grade 3 thrombocytopenia with hemorrhage;
* Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;
* Any othe
Group
Value
95% CI
100 mg/m^2
4
125 mg/m^2
0
150 mg/m^2
1
Number of Participants With Adverse Events (AE)Secondary· Up to 25 months
An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient's treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.
A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Treatment-re
Patients with at least 1 AE
Group
Value
95% CI
100 mg/m^2
20
125 mg/m^2
44
150 mg/m^2
3
At least 1 grade 3 or higher AE
Group
Value
95% CI
100 mg/m^2
15
125 mg/m^2
42
150 mg/m^2
3
At least 1 treatment-related AE
Group
Value
95% CI
100 mg/m^2
18
125 mg/m^2
42
150 mg/m^2
3
At least 1 treatment-related grade 3 to 5 AE
Group
Value
95% CI
100 mg/m^2
11
125 mg/m^2
38
150 mg/m^2
3
Patients with at least 1 SAE
Group
Value
95% CI
100 mg/m^2
10
125 mg/m^2
24
150 mg/m^2
1
Patients with at least 1 treatment-related SAE
Group
Value
95% CI
100 mg/m^2
4
125 mg/m^2
12
150 mg/m^2
1
At least 1 AE and drug permanently discontinued
Group
Value
95% CI
100 mg/m^2
3
125 mg/m^2
12
150 mg/m^2
2
At least 1 TRAE and drug permanently discontinued
Group
Value
95% CI
100 mg/m^2
2
125 mg/m^2
8
150 mg/m^2
2
Percentage of Participants Who Achieved an Objective Confirmed Overall ResponseSecondary· Up to approximately 4 years
Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.
CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.
PR: At least a 30% decrease in the sum of the longest diameters of target le
Group
Value
95% CI
100 mg/m^2
25
8.7 – 49.1
125 mg/m^2
39
24.2 – 53.0
150 mg/m^2
0
NA – NA
Percentage of Participants With Disease ControlSecondary· Up to approximately 4 years
Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.
Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the small
Group
Value
95% CI
100 mg/m^2
55
33.2 – 76.8
125 mg/m^2
55
39.8 – 69.3
150 mg/m^2
33
0.8 – 90.6
Progression-free SurvivalSecondary· Up to approximately 4 years
Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.
Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters re
Group
Value
95% CI
100 mg/m^2
6.1
3.7 – NA
125 mg/m^2
6.9
4.8 – 9.2
150 mg/m^2
1.6
0.5 – 10.0
Duration of ResponseSecondary· Up to approximately 4 years
Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.
Group
Value
95% CI
100 mg/m^2
NA
2.4 – NA
125 mg/m^2
7.3
5.5 – 21.9
Overall SurvivalSecondary· Up to approximately 4 years
Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.
Group
Value
95% CI
100 mg/m^2
9.3
6.6 – 11.9
125 mg/m^2
12.2
8.9 – 17.9
150 mg/m^2
6.1
0.5 – 17.9
Maximal Degree of MyelosuppressionSecondary· During the treatment phase, up to a maximum of 24 months.
The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.
Absolute neutrophil count
Group
Value
95% CI
100 mg/m^2
1.38
± 1.541
125 mg/m^2
0.96
± 1.446
150 mg/m^2
0.47
± 0.460
White blood cell count
Group
Value
95% CI
100 mg/m^2
2.69
± 1.734
125 mg/m^2
2.18
± 1.849
150 mg/m^2
1.52
± 1.484
Platelet count
Group
Value
95% CI
100 mg/m^2
120.3
± 79.02
125 mg/m^2
88.3
± 62.10
150 mg/m^2
58.7
± 48.64
Maximal Degree of AnemiaSecondary· During the treatment phase, up to a maximum of 24 months.
The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.
Group
Value
95% CI
100 mg/m^2
95.1
± 12.85
125 mg/m^2
91.8
± 10.43
150 mg/m^2
95.3
± 15.37
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected up to 30 days after the last dose (a maximum of 25 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
100 mg/m^2
Serious: 10/20 (50%)
Deaths: —
125 mg/m^2
Serious: 24/44 (55%)
Deaths: —
150 mg/m^2
Serious: 1/3 (33%)
Deaths: —
Serious adverse events (48 terms)
Reaction
System
100 mg/m^2
125 mg/m^2
150 mg/m^2
Pyrexia
General disorders
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Bacteraemia
Infections and infestations
—
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
Pain
General disorders
—
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
—
Neutropenic sepsis
Infections and infestations
—
—
—
Abdominal wall abscess
Infections and infestations
—
—
—
Cellulitis
Infections and infestations
—
—
—
Clostridium difficile colitis
Infections and infestations
—
—
—
Endocarditis
Infections and infestations
—
—
—
Infection
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Ascites
Gastrointestinal disorders
—
—
—
Duodenal obstruction
Gastrointestinal disorders
—
—
—
Enterocutaneous fistula
Gastrointestinal disorders
—
—
—
Ileus
Gastrointestinal disorders
—
—
—
Ileus paralytic
Gastrointestinal disorders
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
Obstruction gastric
Gastrointestinal disorders
—
—
—
Other adverse events (191 terms — click to expand)
To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 22 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00398086.