Trial Outcomes & Findings for Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC) (NCT NCT02301143)

Last Updated: 2019-03-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

107 participants

Primary outcome timeframe

Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)

Results posted on

2019-03-20

Participant Flow

152 patients were screened and 107 participants enrolled.

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel Plus Gemcitabine nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period.	Investigator Choice For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. Investigator Choice includes 3 options: 1. Continued on nab-Paclitaxel and gemcitabine 2. Chemoradiation 3. Surgical Intervention
Induction Period STARTED	107	0
Induction Period COMPLETED	62	0
Induction Period NOT COMPLETED	45	0
Investigator's Choice STARTED	0	47
Investigator's Choice COMPLETED	0	37
Investigator's Choice NOT COMPLETED	0	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-Paclitaxel Plus Gemcitabine nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period.	Investigator Choice For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. Investigator Choice includes 3 options: 1. Continued on nab-Paclitaxel and gemcitabine 2. Chemoradiation 3. Surgical Intervention
Induction Period Enrolled But Not Treated	1	0
Induction Period Death	1	0
Induction Period Adverse Event	22	0
Induction Period Progressive Disease	8	0
Induction Period Withdrawal by Subject	3	0
Induction Period Noncompliance with Study Drug	1	0
Induction Period Physician Decision	4	0
Induction Period Symptomatic Deterioration	2	0
Induction Period Protocol Violation	2	0
Induction Period Other	1	0
Investigator's Choice Adverse Event	0	3
Investigator's Choice Progressive Disease	0	3
Investigator's Choice Noncompliance With Study Drug	0	1
Investigator's Choice Symptomatic Deterioration	0	1
Investigator's Choice Other	0	1
Investigator's Choice Unresectable Surgery	0	1

Baseline Characteristics

Baseline CA19-9 measures are missing for six participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants In the Induction period, nab-paclitaxel 125 mg/m\^2 intravenous (IV) infusion was administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period: - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention
Age, Continuous	65.0 years n=107 Participants
Age, Customized <65 years	44 Participants n=107 Participants
Age, Customized >=65 - 75 years	50 Participants n=107 Participants
Age, Customized >75 years	13 Participants n=107 Participants
Sex: Female, Male Female	59 Participants n=107 Participants
Sex: Female, Male Male	48 Participants n=107 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=107 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=107 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=107 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=107 Participants
Race (NIH/OMB) Asian	3 Participants n=107 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=107 Participants
Race (NIH/OMB) Black or African American	2 Participants n=107 Participants
Race (NIH/OMB) White	72 Participants n=107 Participants
Race (NIH/OMB) More than one race	0 Participants n=107 Participants
Race (NIH/OMB) Unknown or Not Reported	30 Participants n=107 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0	50 Participants n=107 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1	57 Participants n=107 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2	0 Participants n=107 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 3	0 Participants n=107 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 4	0 Participants n=107 Participants
Physician Assessment of Peripheral Neuropathy Grade 0	101 Participants n=107 Participants
Physician Assessment of Peripheral Neuropathy Grade 1	6 Participants n=107 Participants
Physician Assessment of Peripheral Neuropathy Grade 2	0 Participants n=107 Participants
Physician Assessment of Peripheral Neuropathy Grade 3	0 Participants n=107 Participants
Physician Assessment of Peripheral Neuropathy Grade 4	0 Participants n=107 Participants
Baseline Albumin	39.0 g/L n=107 Participants
Carbohydrate Antigen 19-9 (CA19-9)	243.3 U/mL n=101 Participants • Baseline CA19-9 measures are missing for six participants.
Baseline Neutrophil - to - Lymphocyte Ratio (NLR) <= 5	91 Participants n=107 Participants
Baseline Neutrophil - to - Lymphocyte Ratio (NLR) > 5	14 Participants n=107 Participants
Baseline Neutrophil - to - Lymphocyte Ratio (NLR) Missing	2 Participants n=107 Participants
Sum of Longest Diameter of Target Lesions	44.0 mm n=107 Participants
Number of Target Lesions	1.0 lesions n=107 Participants
Time from Primary Diagnosis to First Dose	27.0 days n=107 Participants

PRIMARY outcome

Timeframe: Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)

Population: Intent to treat population was defined as all participants enrolled into the study.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
Kaplan-Meier Estimates for Time to Treatment Failure (TTF)	9.0 months Interval 7.26 to 10.05	—

SECONDARY outcome

Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Population: Intent to treat population was defined as all participants enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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	77.6 percentage of participants Interval 70.3 to 83.5	—

SECONDARY outcome

Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Population: Intent to treat population was defined as all participants who were enrolled into the study.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1	39.3 percentage of participants Interval 31.8 to 47.2	—

SECONDARY outcome

Timeframe: Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)

Population: Intent to treat population was defined as all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
Kaplan-Meier Estimate of Progression-Free Survival (PFS)	10.9 months Interval 9.26 to 11.63	—

SECONDARY outcome

Timeframe: Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)

Population: Intent to treat population was defined as all participants who were enrolled into the study.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=107 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
Kaplan-Meier Estimates for Overall Survival (OS)	18.8 months Interval 14.95 to 24.02	—

SECONDARY outcome

Timeframe: 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

Population: Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=95 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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 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 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 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 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 Physical Functioning Scale: Stable	66 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 Physical Functioning Scale: Worsened	9 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 Role Functioning Scale: Improved	36 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 Role Functioning Scale: Stable	46 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 Role Functioning Scale: Worsened	13 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 Emotional Functioning Scale: Improved	50 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 Emotional Functioning Scale: Stable	40 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 Emotional Functioning Scale: Worsened	5 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 Cognitive Functioning Scale: Improved	33 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 Cognitive Functioning Scale: Stable	51 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 Cognitive Functioning Scale: Worsened	11 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 Social Functioning Scale: Improved	38 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 Social Functioning Scale: Stable	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 Social Functioning Scale: Worsened	14 Participants	—

SECONDARY outcome

Timeframe: 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

Population: Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=95 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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 Symptom Scale-Fatigue: Improved	46 Participants	—
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 Symptom Scale-Fatigue: Stable	24 Participants	—
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 Symptom Scale-Fatigue: Worsened	25 Participants	—
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 Scale-Nausea+Vomiting: Improved	29 Participants	—
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 Scale-Nausea+Vomiting: Stable	64 Participants	—
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 Scale-Nausea+Vomiting: Worsened	2 Participants	—
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 Symptom Scale-Pain: Improved	62 Participants	—
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 Symptom Scale-Pain: Stable	29 Participants	—
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 Symptom Scale-Pain: Worsened	4 Participants	—
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 Symptom - Dyspnoea: Improved	12 Participants	—
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 Symptom - Dyspnoea: Stable	74 Participants	—
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 Symptom - Dyspnoea: Worsened	9 Participants	—
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 Symptom - Insomnia: Improved	53 Participants	—
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 Symptom - Insomnia: Stable	35 Participants	—
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 Symptom - Insomnia: Worsened	7 Participants	—
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 Symptom - Appetite loss: Improved	48 Participants	—
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 Symptom - Appetite loss: Stable	39 Participants	—
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 Symptom - Appetite loss: Worsened	8 Participants	—
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 Symptom - Constipation: Improved	46 Participants	—
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 Symptom - Constipation: Stable	45 Participants	—
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 Symptom - Constipation: Worsened	4 Participants	—
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 Symptom - Diarrhoea: Improved	18 Participants	—
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 Symptom - Diarrhoea: Stable	69 Participants	—
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 Symptom - Diarrhoea: Worsened	8 Participants	—
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 Symptom - Financial difficulties: Improved	17 Participants	—
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 Symptom - Financial difficulties: stable:	74 Participants	—
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 Symptom - Financial difficulties: Worsened	4 Participants	—

SECONDARY outcome

Timeframe: 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

Population: Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=95 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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 Pancreatic Pain Scale: Improved	62 Participants	—
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 Pancreatic Pain Scale: Stable	33 Participants	—
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 Pancreatic Pain Scale: Worsened	0 Participants	—
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 Digestive Symptom Scale: Improved	49 Participants	—
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 Digestive Symptom Scale: Stable	36 Participants	—
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 Digestive Symptom Scale: Worsened	10 Participants	—
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 Altered Bowel Habits Scale: Improved	28 Participants	—
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 Altered Bowel Habits Scale: Stable	53 Participants	—
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 Altered Bowel Habits Scale: Worsened	14 Participants	—
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 Hepatic Scale: Improved	25 Participants	—
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 Hepatic Scale: Stable	66 Participants	—
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 Hepatic Scale: Worsened	4 Participants	—
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 Body Image Scale: Improved	22 Participants	—
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 Body Image Scale: Stable	50 Participants	—
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 Body Image Scale: Worsened	23 Participants	—
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 Sexuality Scale: Improved	31 Participants	—
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 Sexuality Scale: Stable	51 Participants	—
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 Sexuality Scale: Worsened	13 Participants	—

SECONDARY outcome

Timeframe: 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

Population: Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=95 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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 Satisfaction with Health Care Scale: Improved	42 Participants	—
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 Satisfaction with Health Care Scale: Stable	40 Participants	—
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 Satisfaction with Health Care Scale: Worsened	13 Participants	—

SECONDARY outcome

Timeframe: 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

Population: Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.

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

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=95 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
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 Abdominal Bloating: Improved	50 Participants	—
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 Abdominal Bloating: Stable	42 Participants	—
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 Abdominal Bloating: Worsened	3 Participants	—
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 Taste Changes: Improved	20 Participants	—
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 Taste Changes: Stable	54 Participants	—
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 Taste Changes: Worsened	21 Participants	—
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 Indigestion: Improved	41 Participants	—
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 Indigestion: Stable	47 Participants	—
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 Indigestion: Worsened	7 Participants	—
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 Flatulence: Improved	47 Participants	—
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 Flatulence: Stable	37 Participants	—
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 Flatulence: Worsened	11 Participants	—
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 Weight Loss: Improved	36 Participants	—
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 Weight Loss: Stable	56 Participants	—
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 Weight Loss: Worsened	3 Participants	—
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 Limb Weakness: Improved	22 Participants	—
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 Limb Weakness: Stable	55 Participants	—
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 Limb Weakness: Worsened	18 Participants	—
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 Dry Mouth: Improved	37 Participants	—
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 Dry Mouth: Stable	45 Participants	—
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 Dry Mouth: Worsened	13 Participants	—
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 Treatment Side-Effects: Improved	8 Participants	—
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 Treatment Side-Effects: Stable	48 Participants	—
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 Treatment Side-Effects: Worsened	39 Participants	—
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 Worry About Future Health: Improved	42 Participants	—
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 Worry About Future Health: Stable	45 Participants	—
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 Worry About Future Health: Worsened	8 Participants	—
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 Limits on Activity Planning: Improved	42 Participants	—
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 Limits on Activity Planning: Stable	42 Participants	—
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 Limits on Activity Planning: Worsened	11 Participants	—

SECONDARY outcome

Timeframe: Day 1 of study drug up to end of the study; up to 31.3 months

Population: The Treated population consists of all participants who received at least 1 dose of nab-paclitaxel or gemcitabine.

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).

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel Plus Gemcitabine n=106 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants who completed 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator then determined the best option for the participant in the Investigator's Choice Period. - Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR - Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR - Surgical intervention	Nab-Paclitaxel Plus Gemcitabine (Overall) n=106 Participants nab-Paclitaxel 125 mg/m\^2 intravenous (IV) infusion administered over approximately 30-45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m\^2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Overall includes nab-Paclitaxel plus Gemcitabine treatment cycles during the Induction Period, as well as the subset of participants who continued the regimen during the Investigator Choice Period.
Participants With Treatment Emergent Adverse Events (TEAEs) >= 1 TEAE	105 Participants	105 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE	102 Participants	103 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 TEAE of severity grade 3 or higher	85 Participants	90 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE of severity grade 3 or higher	72 Participants	75 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 serious TEAE	38 Participants	39 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >= 1 related serious TEAE	14 Participants	14 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 TEAE leading to discontinuation of IP	25 Participants	28 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE leading to discontinuation of IP	15 Participants	18 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 TEAE leading to dose reduction of IP	69 Participants	72 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE leading to dose reduction of IP	68 Participants	71 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 TEAE leading to interruption of IP	66 Participants	68 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE leading to interruption of IP	48 Participants	50 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >= TEAE leading to death	2 Participants	2 Participants
Participants With Treatment Emergent Adverse Events (TEAEs) >=1 related TEAE leading to death	0 Participants	0 Participants

Adverse Events

Nab-Paclitaxel Plus Gemcitabine (Induction Period)

Serious events: 38 serious events

Other events: 104 other events

Deaths: 42 deaths

Nab-Paclitaxel Plus Gemcitabine (Overall)

Serious events: 39 serious events

Other events: 104 other events

Deaths: 67 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER