Trial · NCT02301143
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
NCT02301143, Phase 2, Completed, Celgene; results first posted 2019-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC). Trials, record NCT02301143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02301143
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
- NCT number
- NCT02301143
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Pancreatic Neoplasms
- Interventions
- nab-Paclitaxel, Gemcitabine, Chemoradiation, Capecitabine, Surgery
- First posted
- 2014-11-25
- Last updated
- 2019-03-20
- Results first posted
- 2019-01-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates for Time to Treatment Failure (TTF) | 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 progressive disease (PD) was \>= 20% increase in the sum of diameters of target lesions from nadir, and the sum showed an absolute increase of \>= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression. Median and its 90% confidence interval (CI) of TTF were estimated using the method of Brookmeyer and Crowley. |
| Secondary | 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 1.1 | 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 diagnosed. * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1 | 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 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 diagnosed. The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method |
| Secondary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) | 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 of a non-target lesion or the appearance of any new lesions is also considered progression. Median and its 90% confidence interval of PFS were estimated using the method of Brookmeyer and Crowley. |
| Secondary | Kaplan-Meier Estimates for Overall Survival (OS) | 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 |
| Secondary | 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 Scales | 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 possible quality of life/health status. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: \>=10 increase from baseline - Stable: neither increase nor decrease \>10 - Worsened: \>=10 decrease from baseline |
| Secondary | 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 Items | 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 score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: \>=10 decrease from baseline - Stable: neither increase nor decrease \>10 - Worsened: \>=10 increase from baseline |
| Secondary | 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 Scales | 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 is the best score from all post-baseline visits and is compared to the baseline. Responder categories: - Improved: \>=MID decrease from baseline - Stable: no increase or decrease \>MID - Worsened: \>=MID increase from baseline MID = half the baseline standard deviation |
| Secondary | 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 Scale | 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 post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: \>=MID increase from baseline - Stable: no increase or decrease \>MID - Worsened: \>=MID decrease from baseline MID = half the baseline standard deviation |
| Secondary | 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 Scores | 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 the following responder categories. Responder categories: - Improved: \>=MID decrease from baseline - Stable: no increase or decrease \>MID - Worsened: \>=MID increase from baseline MID = half the baseline standard deviation |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates for Time to Treatment Failure (TTF) | Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment) | Intent to treat population was defined as all participants enrolled into the study. | months | MEDIAN |
| SECONDARY | 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 1.1 | Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks | Intent to treat population was defined as all participants enrolled into the study. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1 | Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks | Intent to treat population was defined as all participants who were enrolled into the study. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Progression-Free Survival (PFS) | Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment) | Intent to treat population was defined as all participants who were enrolled into the study. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Overall Survival (OS) | Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up) | Intent to treat population was defined as all participants who were enrolled into the study. | months | MEDIAN |
| SECONDARY | 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 Scales | 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 | Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 Items | 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 | Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 Scales | 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 | Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 Scale | 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 | Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 Scores | 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 | Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Time to Treatment Failure (TTF) | Nab-Paclitaxel Plus Gemcitabine | 9.0 | 90% Confidence Interval 7.26 to 10.05 | months | |
| 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 1.1 | Nab-Paclitaxel Plus Gemcitabine | 77.6 | 90% Confidence Interval 70.3 to 83.5 | percentage of participants | |
| Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1 | Nab-Paclitaxel Plus Gemcitabine | 39.3 | 90% Confidence Interval 31.8 to 47.2 | percentage of participants | |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) | Nab-Paclitaxel Plus Gemcitabine | 10.9 | 90% Confidence Interval 9.26 to 11.63 | months | |
| Kaplan-Meier Estimates for Overall Survival (OS) | Nab-Paclitaxel Plus Gemcitabine | 18.8 | 90% Confidence Interval 14.95 to 24.02 | months | |
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 Scales | Nab-Paclitaxel Plus Gemcitabine | Global Health Status: Improved | 43 | Participants | |
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 Scales | Nab-Paclitaxel Plus Gemcitabine | Global Health Status: Stable | 34 | Participants | |
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 Scales | Nab-Paclitaxel Plus Gemcitabine | Global Health Status: Worsened | 18 | Participants | |
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 Scales | Nab-Paclitaxel Plus Gemcitabine | Physical Functioning Scale: Improved | 20 | Participants | |
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 Scales | Nab-Paclitaxel Plus Gemcitabine | Physical Functioning Scale: Stable | 66 | Participants |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Nab-Paclitaxel Plus Gemcitabine | 107 | |
| Induction Period | STARTED | Investigator Choice | 0 | |
| Induction Period | COMPLETED | Nab-Paclitaxel Plus Gemcitabine | 62 | |
| Induction Period | COMPLETED | Investigator Choice | 0 | |
| Induction Period | NOT COMPLETED | Nab-Paclitaxel Plus Gemcitabine | 45 | |
| Induction Period | NOT COMPLETED | Investigator Choice | 0 | |
| Investigator's Choice | STARTED | Nab-Paclitaxel Plus Gemcitabine | 0 | |
| Investigator's Choice | STARTED | Investigator Choice | 47 | |
| Investigator's Choice | COMPLETED | Nab-Paclitaxel Plus Gemcitabine | 0 | |
| Investigator's Choice | COMPLETED | Investigator Choice | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 49 | 106 | |
| other | Anaemia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Overall) | 49 | 106 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 7 | 106 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Overall) | 7 | 106 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 6 | 106 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Overall) | 6 | 106 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 44 | 106 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Overall) | 45 | 106 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 25 | 106 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nab-Paclitaxel Plus Gemcitabine (Overall) | 27 | 106 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 42 | 106 |
| Total, all-cause mortality | Nab-Paclitaxel Plus Gemcitabine (Overall) | 67 | 106 |
| Total, other adverse events | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 104 | 106 |
| Total, other adverse events | Nab-Paclitaxel Plus Gemcitabine (Overall) | 104 | 106 |
| Total, serious adverse events | Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 38 | 106 |
| Total, serious adverse events | Nab-Paclitaxel Plus Gemcitabine (Overall) | 39 | 106 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31953079 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nab-Paclitaxel Plus Gemcitabine (Induction Period) vs Nab-Paclitaxel Plus Gemcitabine (Overall): deaths from any cause | Trial comparisons |
| Nab-Paclitaxel Plus Gemcitabine (Induction Period) vs Nab-Paclitaxel Plus Gemcitabine (Overall): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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