Adults 18 to 79, 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.
Overall Survival (OS)Primary· From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
8.5
7.89 – 9.53
Gemcitabine
6.7
6.01 – 7.23
Progression-free Survival (PFS) by Independent Radiological Review (IRR)Secondary· 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.
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progres
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
5.5
4.47 – 5.95
Gemcitabine
3.7
3.61 – 4.04
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)Secondary· Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest di
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
23
19.1 – 27.2
Gemcitabine
7
5.0 – 10.1
Participants With Treatment Emergent Adverse Events (AE)Secondary· Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
At least 1 AE
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
417
Gemcitabine
395
≥ 1 Treatment related AE (TEAE)
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
403
Gemcitabine
371
At least 1 Serious Adverse Event (SAE)
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
212
Gemcitabine
172
≥ 1 treatment related SAE
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
121
Gemcitabine
53
≥ 1 Grade (GR) 3/4 AE
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
370
Gemcitabine
298
≥ 1 Grade 3 or higher AE
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
374
Gemcitabine
303
≥ 1 AE leading to stopping treatment
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
149
Gemcitabine
95
≥ 1 AE leading to death
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
18
Gemcitabine
18
Number of Participants With Dose ReductionsSecondary· Maximum time on treatment was 666 days
The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
At least 1 alumbin bound paclitaxel dose reduction
Number of Participants With Dose InterruptionsSecondary· Maximum time on treatment was 666 days
The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
≥ 1 Albumin-bound paclitaxel dose interruption
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
2
Gemcitabine
0
At least 1 Gemcitabine dose interruption
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
8
Gemcitabine
9
Number of Participants With Dose Delays/Doses Not GivenSecondary· Up to 666 days
The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
At least 1 ABI-007 dose delay/Not given
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
300
Gemcitabine
0
At least ≥ 1 Gem dose delay/Not given
Group
Value
95% CI
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
295
Gemcitabine
230
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 up to 30 days after the last dose (a maximum of 666 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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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: 25 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/NCT00844649.