LAPACT: Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02301143
• Collaborator: (none)
• Enrollment: 107
• Locations: 42
• Arm: 1
• Actual Duration (Months): 36.2
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Drug: nab-Paclitaxel; Drug: Gemcitabine; Drug: Chemoradiation; Drug: Capecitabine; Procedure: Surgery	Phase 2

Detailed Description

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).
• Actual Study Start Date: Apr 21, 2015
• Actual Primary Completion Date: Nov 21, 2017
• Actual Study Completion Date: Apr 26, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: nab-Paclitaxel plus Gemcitabine nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject. 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

Drug: nab-Paclitaxel; Other Names: Abraxane ; Drug: Gemcitabine; Other Names: Gemzar ; Drug: Chemoradiation; Drug: Capecitabine; Procedure: Surgery; Surgical intervention

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

3. 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.

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Participants With Treatment Emergent Adverse Events (TEAEs) [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 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

• No prior anticancer therapy for pancreatic cancer

•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function

• Signed informed Consent

Exclusion Criteria:

• Active bacterial, viral, or fungal infection

• Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive

• Subjects with sensory neuropathy, ascites, or plastic biliary stent.

• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)

• Women who are pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic - Arizona	Scottsdale	Arizona	United States	85259
2	UC Davis Cancer Center	Sacramento	California	United States	95817
3	Scripps Clinic Torrey Pines	San Diego	California	United States	92037
4	Smilow Cancer Hospital At Yale-New Haven	New Haven	Connecticut	United States	06510
5	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia	United States	20007
6	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
7	Piedmont Cancer Institute PC	Atlanta	Georgia	United States	30318
8	Cancer Treatment Centers of America - Southeastern Regional Medical Center	Newnan	Georgia	United States	30265
9	ME Center for Cancer Medicine	Scarborough	Maine	United States	04074
10	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
11	University of Massachusetts	Worcester	Massachusetts	United States	01655
12	Saint Joseph Mercy Ann Arbor Hospital	Ann Arbor	Michigan	United States	48106
13	Karmanos Cancer Center Wayne State University	Detroit	Michigan	United States	48201
14	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
15	Regional Cancer Care Associates LLC	Morristown	New Jersey	United States	07962
16	Montefiore Einstein Cancer Center	Bronx	New York	United States	10461
17	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
18	Clinical Research Alliance	Lake Success	New York	United States	11042
19	State University of New York Upstate Medical Center	Syracuse	New York	United States	13215
20	Levine Cancer Institute	Charlotte	North Carolina	United States	28204
21	Mark H Zangmeister Center	Columbus	Ohio	United States	43219
22	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-5505
23	Houston Methodist Cancer Center	Houston	Texas	United States	77030
24	Tom Baker Cancer Center	Calgary	Alberta	Canada	T2N 4N2
25	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
26	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
27	CHUM Hôpital Saint-Luc	Montreal	Quebec	Canada	H2L 4M1
28	McGill University	Montreal	Quebec	Canada	H2W 1S6
29	Centre Regional de lutte contre le cancer Paul Papin	Angers		France	49933
30	CHRU Besancon	Besançon		France	25000
31	Centre Hospitalier Belfort Montbeliard	Besançon		France
32	Hopital Beaujon	Clichy cedex		France
33	Hopital Saint Antoine	Paris		France	75012
34	Hopital Haut Leveque	Pessac Cedex		France	33604
35	Ospedale Sacro Cuore di Gesu FatebeneFratelli	Benevento		Italy	82100
36	Azienda Ospedaliera Universitaria San Martino	Genova		Italy	16132
37	Policlinico Universitario Campus Biomedico Di Roma	Roma		Italy	128
38	Hospital Universitario a Coruna	A Coruna		Spain	15006
39	ICO-Hospital Germans Trias i Pujol	Barcelona		Spain	08916
40	Hospital Clinico San Carlos	Madrid		Spain	28040
41	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008
42	Hospital Miguel Servet	Zaragoza		Spain	50009

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Teng Jin Ong, MD, Celgene

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 13, 2017
• Study Protocol - Feb 6, 2018

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT02301143
• Other Study ID Numbers: ABI-007-PANC-007
• First Posted: Nov 25, 2014
• Last Update Posted: Mar 20, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Celgene: Pancreatic Neoplasms; Pancreatic Cancer; Locally advanced pacriatic cancer; nab-Paclitaxel; Abraxane; Gemcitabine; ABI-007
• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Paclitaxel; Capecitabine

Study Results

Participant Flow

Pre-assignment Detail	152 patients were screened and 107 participants enrolled.

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine	Investigator Choice
Arm/Group Description	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.	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
Period Title: Induction Period
STARTED	107	0
COMPLETED	62	0
NOT COMPLETED	45	0
Period Title: Induction Period
STARTED	0	47
COMPLETED	0	37
NOT COMPLETED	0	10

Baseline Characteristics

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Overall Participants	107
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	65.0
Age, Customized (Count of Participants)
<65 years	44 41.1%
>=65 - 75 years	50 46.7%
>75 years	13 12.1%
Sex: Female, Male (Count of Participants)
Female	59 55.1%
Male	48 44.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 0.9%
Not Hispanic or Latino	78 72.9%
Unknown or Not Reported	28 26.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 2.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 1.9%
White	72 67.3%
More than one race	0 0%
Unknown or Not Reported	30 28%
Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
Grade 0	50 46.7%
Grade 1	57 53.3%
Grade 2	0 0%
Grade 3	0 0%
Grade 4	0 0%
Physician Assessment of Peripheral Neuropathy (Count of Participants)
Grade 0	101 94.4%
Grade 1	6 5.6%
Grade 2	0 0%
Grade 3	0 0%
Grade 4	0 0%
Baseline Albumin (g/L) [Median (Full Range) ]
Median (Full Range) [g/L]	39.0
Carbohydrate Antigen 19-9 (CA19-9) (U/mL) [Median (Full Range) ]
Median (Full Range) [U/mL]	243.3
Baseline Neutrophil - to - Lymphocyte Ratio (NLR) (Count of Participants)
<= 5	91 85%
> 5	14 13.1%
Missing	2 1.9%
Sum of Longest Diameter of Target Lesions (mm) [Median (Full Range) ]
Median (Full Range) [mm]	44.0
Number of Target Lesions (lesions) [Median (Full Range) ]
Median (Full Range) [lesions]	1.0
Time from Primary Diagnosis to First Dose (days) [Median (Full Range) ]
Median (Full Range) [days]	27.0

Outcome Measures

1. Primary Outcome

Title	Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
Description	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.
Time Frame	Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Measure Participants	107
Median (90% Confidence Interval) [months]	9.0

2. Secondary Outcome

Title	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
Description	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.
Time Frame	Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Measure Participants	107
Number (90% Confidence Interval) [percentage of participants]	77.6 72.5%

3. Secondary Outcome

Title	Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1
Description	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
Time Frame	Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Measure Participants	107
Number (90% Confidence Interval) [percentage of participants]	39.3 36.7%

4. Secondary Outcome

Title	Kaplan-Meier Estimate of Progression-Free Survival (PFS)
Description	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.
Time Frame	Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Measure Participants	107
Median (90% Confidence Interval) [months]	10.9

5. Secondary Outcome

Title	Kaplan-Meier Estimates for Overall Survival (OS)
Description	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
Time Frame	Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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
Measure Participants	107
Median (90% Confidence Interval) [months]	18.8

6. Secondary Outcome

Title	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
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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 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 - 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
Measure Participants	95
Global Health Status: Improved	43 40.2%
Global Health Status: Stable	34 31.8%
Global Health Status: Worsened	18 16.8%
Physical Functioning Scale: Improved	20 18.7%
Physical Functioning Scale: Stable	66 61.7%
Physical Functioning Scale: Worsened	9 8.4%
Role Functioning Scale: Improved	36 33.6%
Role Functioning Scale: Stable	46 43%
Role Functioning Scale: Worsened	13 12.1%
Emotional Functioning Scale: Improved	50 46.7%
Emotional Functioning Scale: Stable	40 37.4%
Emotional Functioning Scale: Worsened	5 4.7%
Cognitive Functioning Scale: Improved	33 30.8%
Cognitive Functioning Scale: Stable	51 47.7%
Cognitive Functioning Scale: Worsened	11 10.3%
Social Functioning Scale: Improved	38 35.5%
Social Functioning Scale: Stable	43 40.2%
Social Functioning Scale: Worsened	14 13.1%

7. Secondary Outcome

Title	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
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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, 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
Measure Participants	95
Symptom Scale-Fatigue: Improved	46 43%
Symptom Scale-Fatigue: Stable	24 22.4%
Symptom Scale-Fatigue: Worsened	25 23.4%
Scale-Nausea+Vomiting: Improved	29 27.1%
Scale-Nausea+Vomiting: Stable	64 59.8%
Scale-Nausea+Vomiting: Worsened	2 1.9%
Symptom Scale-Pain: Improved	62 57.9%
Symptom Scale-Pain: Stable	29 27.1%
Symptom Scale-Pain: Worsened	4 3.7%
Symptom - Dyspnoea: Improved	12 11.2%
Symptom - Dyspnoea: Stable	74 69.2%
Symptom - Dyspnoea: Worsened	9 8.4%
Symptom - Insomnia: Improved	53 49.5%
Symptom - Insomnia: Stable	35 32.7%
Symptom - Insomnia: Worsened	7 6.5%
Symptom - Appetite loss: Improved	48 44.9%
Symptom - Appetite loss: Stable	39 36.4%
Symptom - Appetite loss: Worsened	8 7.5%
Symptom - Constipation: Improved	46 43%
Symptom - Constipation: Stable	45 42.1%
Symptom - Constipation: Worsened	4 3.7%
Symptom - Diarrhoea: Improved	18 16.8%
Symptom - Diarrhoea: Stable	69 64.5%
Symptom - Diarrhoea: Worsened	8 7.5%
Symptom - Financial difficulties: Improved	17 15.9%
Symptom - Financial difficulties: stable:	74 69.2%
Symptom - Financial difficulties: Worsened	4 3.7%

8. Secondary Outcome

Title	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
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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 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
Measure Participants	95
Pancreatic Pain Scale: Improved	62 57.9%
Pancreatic Pain Scale: Stable	33 30.8%
Pancreatic Pain Scale: Worsened	0 0%
Digestive Symptom Scale: Improved	49 45.8%
Digestive Symptom Scale: Stable	36 33.6%
Digestive Symptom Scale: Worsened	10 9.3%
Altered Bowel Habits Scale: Improved	28 26.2%
Altered Bowel Habits Scale: Stable	53 49.5%
Altered Bowel Habits Scale: Worsened	14 13.1%
Hepatic Scale: Improved	25 23.4%
Hepatic Scale: Stable	66 61.7%
Hepatic Scale: Worsened	4 3.7%
Body Image Scale: Improved	22 20.6%
Body Image Scale: Stable	50 46.7%
Body Image Scale: Worsened	23 21.5%
Sexuality Scale: Improved	31 29%
Sexuality Scale: Stable	51 47.7%
Sexuality Scale: Worsened	13 12.1%

9. Secondary Outcome

Title	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
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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, 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
Measure Participants	95
Satisfaction with Health Care Scale: Improved	42 39.3%
Satisfaction with Health Care Scale: Stable	40 37.4%
Satisfaction with Health Care Scale: Worsened	13 12.1%

10. Secondary Outcome

Title	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
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine
Arm/Group Description	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.
Measure Participants	95
Abdominal Bloating: Improved	50 46.7%
Abdominal Bloating: Stable	42 39.3%
Abdominal Bloating: Worsened	3 2.8%
Taste Changes: Improved	20 18.7%
Taste Changes: Stable	54 50.5%
Taste Changes: Worsened	21 19.6%
Indigestion: Improved	41 38.3%
Indigestion: Stable	47 43.9%
Indigestion: Worsened	7 6.5%
Flatulence: Improved	47 43.9%
Flatulence: Stable	37 34.6%
Flatulence: Worsened	11 10.3%
Weight Loss: Improved	36 33.6%
Weight Loss: Stable	56 52.3%
Weight Loss: Worsened	3 2.8%
Limb Weakness: Improved	22 20.6%
Limb Weakness: Stable	55 51.4%
Limb Weakness: Worsened	18 16.8%
Dry Mouth: Improved	37 34.6%
Dry Mouth: Stable	45 42.1%
Dry Mouth: Worsened	13 12.1%
Treatment Side-Effects: Improved	8 7.5%
Treatment Side-Effects: Stable	48 44.9%
Treatment Side-Effects: Worsened	39 36.4%
Worry About Future Health: Improved	42 39.3%
Worry About Future Health: Stable	45 42.1%
Worry About Future Health: Worsened	8 7.5%
Limits on Activity Planning: Improved	42 39.3%
Limits on Activity Planning: Stable	42 39.3%
Limits on Activity Planning: Worsened	11 10.3%

11. Secondary Outcome

Title	Participants With Treatment Emergent Adverse Events (TEAEs)
Description	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).
Time Frame	Day 1 of study drug up to end of the study; up to 31.3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine (Induction Period)	Nab-Paclitaxel Plus Gemcitabine (Overall)
Arm/Group Description	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. Six treatment cycles were planned.	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.
Measure Participants	106	106
>= 1 TEAE	105 98.1%	105 NaN
>=1 related TEAE	102 95.3%	103 NaN
>=1 TEAE of severity grade 3 or higher	85 79.4%	90 NaN
>=1 related TEAE of severity grade 3 or higher	72 67.3%	75 NaN
>=1 serious TEAE	38 35.5%	39 NaN
>= 1 related serious TEAE	14 13.1%	14 NaN
>=1 TEAE leading to discontinuation of IP	25 23.4%	28 NaN
>=1 related TEAE leading to discontinuation of IP	15 14%	18 NaN
>=1 TEAE leading to dose reduction of IP	69 64.5%	72 NaN
>=1 related TEAE leading to dose reduction of IP	68 63.6%	71 NaN
>=1 TEAE leading to interruption of IP	66 61.7%	68 NaN
>=1 related TEAE leading to interruption of IP	48 44.9%	50 NaN
>= TEAE leading to death	2 1.9%	2 NaN
>=1 related TEAE leading to death	0 0%	0 NaN

Adverse Events

Time Frame	Day 1 of study drug up to end of the study; up to 31.3 months
Adverse Event Reporting Description	One participant was enrolled but not treated. The safety population consisted of participants who received at least one dose of nab-paclitaxel.
Arm/Group Title	Nab-Paclitaxel Plus Gemcitabine (Induction Period)		Nab-Paclitaxel Plus Gemcitabine (Overall)
Arm/Group Description	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.		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.
All Cause Mortality
	Nab-Paclitaxel Plus Gemcitabine (Induction Period)		Nab-Paclitaxel Plus Gemcitabine (Overall)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/106 (39.6%)		67/106 (63.2%)
Serious Adverse Events
	Nab-Paclitaxel Plus Gemcitabine (Induction Period)		Nab-Paclitaxel Plus Gemcitabine (Overall)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/106 (35.8%)		39/106 (36.8%)
Blood and lymphatic system disorders
Febrile neutropenia	3/106 (2.8%)		3/106 (2.8%)
Neutropenia	1/106 (0.9%)		1/106 (0.9%)
Cardiac disorders
Acute coronary syndrome	1/106 (0.9%)		1/106 (0.9%)
Atrial fibrillation	2/106 (1.9%)		2/106 (1.9%)
Cardiac arrest	1/106 (0.9%)		1/106 (0.9%)
Gastrointestinal disorders
Abdominal pain	2/106 (1.9%)		2/106 (1.9%)
Constipation	1/106 (0.9%)		1/106 (0.9%)
Diarrhoea	1/106 (0.9%)		1/106 (0.9%)
Obstruction gastric	1/106 (0.9%)		1/106 (0.9%)
Pancreatitis	1/106 (0.9%)		1/106 (0.9%)
Vomiting	0/106 (0%)		1/106 (0.9%)
General disorders
Death	1/106 (0.9%)		1/106 (0.9%)
General physical health deterioration	1/106 (0.9%)		1/106 (0.9%)
Generalised oedema	1/106 (0.9%)		1/106 (0.9%)
Influenza like illness	1/106 (0.9%)		1/106 (0.9%)
Malaise	1/106 (0.9%)		1/106 (0.9%)
Pyrexia	5/106 (4.7%)		5/106 (4.7%)
Hepatobiliary disorders
Cholangitis	1/106 (0.9%)		1/106 (0.9%)
Cholecystitis	1/106 (0.9%)		1/106 (0.9%)
Cholecystitis acute	1/106 (0.9%)		1/106 (0.9%)
Hepatic cirrhosis	1/106 (0.9%)		1/106 (0.9%)
Jaundice cholestatic	1/106 (0.9%)		1/106 (0.9%)
Infections and infestations
Cellulitis	2/106 (1.9%)		2/106 (1.9%)
Clostridium difficile colitis	1/106 (0.9%)		1/106 (0.9%)
Escherichia sepsis	1/106 (0.9%)		1/106 (0.9%)
Gastroenteritis Escherichia coli	1/106 (0.9%)		1/106 (0.9%)
Liver abscess	0/106 (0%)		1/106 (0.9%)
Lung infection	1/106 (0.9%)		1/106 (0.9%)
Neutropenic sepsis	2/106 (1.9%)		2/106 (1.9%)
Pancreas infection	1/106 (0.9%)		1/106 (0.9%)
Parainfluenzae virus infection	1/106 (0.9%)		1/106 (0.9%)
Pneumonia	5/106 (4.7%)		5/106 (4.7%)
Sepsis	2/106 (1.9%)		2/106 (1.9%)
Injury, poisoning and procedural complications
Peripancreatic fluid collection	1/106 (0.9%)		1/106 (0.9%)
Spinal compression fracture	1/106 (0.9%)		1/106 (0.9%)
Investigations
Blood bilirubin increased	1/106 (0.9%)		1/106 (0.9%)
Metabolism and nutrition disorders
Dehydration	1/106 (0.9%)		1/106 (0.9%)
Nervous system disorders
Presyncope	1/106 (0.9%)		1/106 (0.9%)
Renal and urinary disorders
Obstructive uropathy	1/106 (0.9%)		1/106 (0.9%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	1/106 (0.9%)		1/106 (0.9%)
Pneumonitis	1/106 (0.9%)		1/106 (0.9%)
Pulmonary embolism	1/106 (0.9%)		1/106 (0.9%)
Vascular disorders
Hypotension	1/106 (0.9%)		1/106 (0.9%)
Jugular vein thrombosis	1/106 (0.9%)		1/106 (0.9%)
Other (Not Including Serious) Adverse Events
	Nab-Paclitaxel Plus Gemcitabine (Induction Period)		Nab-Paclitaxel Plus Gemcitabine (Overall)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	104/106 (98.1%)		104/106 (98.1%)
Blood and lymphatic system disorders
Anaemia	49/106 (46.2%)		49/106 (46.2%)
Leukopenia	7/106 (6.6%)		7/106 (6.6%)
Lymphopenia	6/106 (5.7%)		6/106 (5.7%)
Neutropenia	44/106 (41.5%)		45/106 (42.5%)
Thrombocytopenia	25/106 (23.6%)		27/106 (25.5%)
Gastrointestinal disorders
Abdominal pain	19/106 (17.9%)		19/106 (17.9%)
Abdominal pain upper	9/106 (8.5%)		10/106 (9.4%)
Constipation	30/106 (28.3%)		32/106 (30.2%)
Diarrhoea	48/106 (45.3%)		48/106 (45.3%)
Dry mouth	7/106 (6.6%)		7/106 (6.6%)
Dyspepsia	7/106 (6.6%)		8/106 (7.5%)
Nausea	46/106 (43.4%)		47/106 (44.3%)
Stomatitis	20/106 (18.9%)		20/106 (18.9%)
Vomiting	30/106 (28.3%)		30/106 (28.3%)
General disorders
Asthenia	36/106 (34%)		36/106 (34%)
Chills	18/106 (17%)		18/106 (17%)
Fatigue	53/106 (50%)		53/106 (50%)
Influenza like illness	7/106 (6.6%)		8/106 (7.5%)
Oedema peripheral	45/106 (42.5%)		47/106 (44.3%)
Pain	5/106 (4.7%)		6/106 (5.7%)
Pyrexia	39/106 (36.8%)		40/106 (37.7%)
Infections and infestations
Upper respiratory tract infection	6/106 (5.7%)		7/106 (6.6%)
Investigations
Alanine aminotransferase increased	21/106 (19.8%)		23/106 (21.7%)
Aspartate aminotransferase increased	16/106 (15.1%)		17/106 (16%)
Blood alkaline phosphatase increased	14/106 (13.2%)		16/106 (15.1%)
Gamma-glutamyltransferase increased	6/106 (5.7%)		6/106 (5.7%)
Neutrophil count decreased	22/106 (20.8%)		23/106 (21.7%)
Platelet count decreased	25/106 (23.6%)		27/106 (25.5%)
Weight decreased	12/106 (11.3%)		12/106 (11.3%)
White blood cell count decreased	14/106 (13.2%)		14/106 (13.2%)
Metabolism and nutrition disorders
Decreased appetite	46/106 (43.4%)		46/106 (43.4%)
Dehydration	11/106 (10.4%)		11/106 (10.4%)
Hyperglycaemia	12/106 (11.3%)		12/106 (11.3%)
Hyperkalaemia	6/106 (5.7%)		6/106 (5.7%)
Hypoalbuminaemia	11/106 (10.4%)		11/106 (10.4%)
Hypokalaemia	14/106 (13.2%)		14/106 (13.2%)
Hypomagnesaemia	7/106 (6.6%)		7/106 (6.6%)
Hyponatraemia	10/106 (9.4%)		10/106 (9.4%)
Iron deficiency	7/106 (6.6%)		7/106 (6.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/106 (8.5%)		10/106 (9.4%)
Back pain	16/106 (15.1%)		17/106 (16%)
Bone pain	6/106 (5.7%)		6/106 (5.7%)
Muscular weakness	6/106 (5.7%)		7/106 (6.6%)
Myalgia	12/106 (11.3%)		12/106 (11.3%)
Nervous system disorders
Dizziness	10/106 (9.4%)		12/106 (11.3%)
Dysgeusia	32/106 (30.2%)		33/106 (31.1%)
Headache	17/106 (16%)		17/106 (16%)
Neuropathy peripheral	23/106 (21.7%)		25/106 (23.6%)
Paraesthesia	11/106 (10.4%)		11/106 (10.4%)
Peripheral sensory neuropathy	29/106 (27.4%)		30/106 (28.3%)
Psychiatric disorders
Anxiety	15/106 (14.2%)		15/106 (14.2%)
Depression	6/106 (5.7%)		6/106 (5.7%)
Insomnia	11/106 (10.4%)		11/106 (10.4%)
Respiratory, thoracic and mediastinal disorders
Cough	24/106 (22.6%)		25/106 (23.6%)
Dyspnoea	14/106 (13.2%)		15/106 (14.2%)
Epistaxis	9/106 (8.5%)		9/106 (8.5%)
Skin and subcutaneous tissue disorders
Alopecia	57/106 (53.8%)		57/106 (53.8%)
Dermatitis acneiform	9/106 (8.5%)		9/106 (8.5%)
Dry skin	8/106 (7.5%)		9/106 (8.5%)
Pruritus	11/106 (10.4%)		12/106 (11.3%)
Rash maculo-papular	9/106 (8.5%)		9/106 (8.5%)
Vascular disorders
Hypotension	8/106 (7.5%)		8/106 (7.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.