18 and older, any sex, with Pancreatic Neoplasms. 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.
Kaplan-Meier Estimates for Time to Treatment Failure (TTF)Primary· Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)
TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. If a participant does not progress, die or start a new non-protocol-defined anticancer therapy, the participant was censored on the last tumor assessment date.
Tumor evaluations of CT or MRI scans were assessed by the investigative sites and response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1.
The definition for prog
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
9.0
7.26 – 10.05
Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1Secondary· Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.
RECIST 1.1 Definition:
* CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to \< 10 mm and no new lesions diagnosed.
* PR: a \>= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
77.6
70.3 – 83.5
Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1Secondary· Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator. Assessments after new non-protocol-defined anticancer therapy are excluded. For participants who had resectable surgery in Investigator Choice period, assessments after surgical intervention are excluded.
RECIST 1.1 Definition:
* CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to \< 10 mm and no new lesions diagno
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
39.3
31.8 – 47.2
Kaplan-Meier Estimate of Progression-Free Survival (PFS)Secondary· Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)
Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.
The definition for progressive disease (PD) was at least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of \>= 5 mm; the progression
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
10.9
9.26 – 11.63
Kaplan-Meier Estimates for Overall Survival (OS)Secondary· Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)
Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause). Participants who were alive at the end of study or clinical data cut were censored on the last known time that the participant was alive or the clinical cutoff date, whichever was earlier. Median and its 90% confidence interval of OS were estimated using the method of Brookmeyer and Crowley
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
18.8
14.95 – 24.02
Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning ScalesSecondary· Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 - 100 scale. In the Global Health Status and 5 functional scales, 0 = worst possible quality of life/health status and 100 = best possibl
Global Health Status: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
43
Global Health Status: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
34
Global Health Status: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
18
Physical Functioning Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
20
Physical Functioning Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
66
Physical Functioning Scale: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
9
Role Functioning Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
36
Role Functioning Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
46
Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom ItemsSecondary· Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 to 100 scale. In the symptom scales and single symptom items, 0 = optimal health state and 100 = worst possible health state. The best sc
Symptom Scale-Fatigue: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
46
Symptom Scale-Fatigue: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
24
Symptom Scale-Fatigue: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
25
Scale-Nausea+Vomiting: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
29
Scale-Nausea+Vomiting: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
64
Scale-Nausea+Vomiting: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
2
Symptom Scale-Pain: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
62
Symptom Scale-Pain: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
29
Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary ScalesSecondary· Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. All reported measures are transformed to a 0 to 100 scale. Six summary scales reported are: - Pancreatic Pain - Digestive Symptoms - Altered Bowel Habits - Hepatic Scale - Body Image - Sexuality Scores of 0 = optimal health state and 100 = worst possible health state. The best score on treatment
Pancreatic Pain Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
62
Pancreatic Pain Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
33
Pancreatic Pain Scale: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
0
Digestive Symptom Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
49
Digestive Symptom Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
36
Digestive Symptom Scale: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
10
Altered Bowel Habits Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
28
Altered Bowel Habits Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
53
Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care ScaleSecondary· Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The summary scale for Satisfaction with Health Care is reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = not satisfied, worst possible health state and 100 = extremely satisfied, best possible health state. The best score on treatment is the best score from all po
Satisfaction with Health Care Scale: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
42
Satisfaction with Health Care Scale: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
40
Satisfaction with Health Care Scale: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
13
Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item ScoresSecondary· Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The 10 individual item scores are reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = best possible health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get
Abdominal Bloating: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
50
Abdominal Bloating: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
42
Abdominal Bloating: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
3
Taste Changes: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
20
Taste Changes: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
54
Taste Changes: Worsened
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
21
Indigestion: Improved
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
41
Indigestion: Stable
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine
47
Participants With Treatment Emergent Adverse Events (TEAEs)Secondary· Day 1 of study drug up to end of the study; up to 31.3 months
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
>= 1 TEAE
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
105
Nab-Paclitaxel Plus Gemcitabine (Overall)
105
>=1 related TEAE
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
102
Nab-Paclitaxel Plus Gemcitabine (Overall)
103
>=1 TEAE of severity grade 3 or higher
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
85
Nab-Paclitaxel Plus Gemcitabine (Overall)
90
>=1 related TEAE of severity grade 3 or higher
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
72
Nab-Paclitaxel Plus Gemcitabine (Overall)
75
>=1 serious TEAE
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
38
Nab-Paclitaxel Plus Gemcitabine (Overall)
39
>= 1 related serious TEAE
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
14
Nab-Paclitaxel Plus Gemcitabine (Overall)
14
>=1 TEAE leading to discontinuation of IP
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
25
Nab-Paclitaxel Plus Gemcitabine (Overall)
28
>=1 related TEAE leading to discontinuation of IP
Group
Value
95% CI
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
15
Nab-Paclitaxel Plus Gemcitabine (Overall)
18
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 of study drug up to end of the study; up to 31.3 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nab-Paclitaxel Plus Gemcitabine (Induction Period)
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced 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 9 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: 20 March 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/NCT02301143.