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CompletedNCT01964430apactUpdated Jun 28, 2023Results posted

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

A Phase 3 interventional study of nab-Paclitaxel and Gemcitabine in Pancreatic Neoplasms, Digestive System Neoplasms and Neoplasms by Site, sponsored by Celgene. Completed at 341 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Celgene · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
866
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

Read the detailed description

ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.

02

Conditions studied

  • Pancreatic Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Endocrine Gland Neoplasms
  • Pancreatic Diseases
  • Digestive System Diseases
  • Endocrine System Diseases
  • Gemcitabine
  • Antimetabolites, Antineoplastic

Keywords

  • Resectable pancreatic cancer
  • resected
  • resectable PDA
  • adenocarcinoma
  • surgically resected
  • adjuvant
  • Abraxane
  • nab-paclitaxel
  • ABI-007
  • gemcitabine
  • Gemzar
  • Phase 3
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 866 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
  2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
  3. Subject should be able to start treatment no later than 12 weeks postsurgery.
  4. ≥18 years of age at the time of signing the informed consent form (ICF).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  6. Acceptable hematology parameters:

    • Absolute neutrophil count (ANC) ≥1500 cell/mm\^3
    • Platelet count ≥100,000/mm\^3
    • Hemoglobin (Hgb) ≥9 g/dL

  7. Acceptable blood chemistry levels:

    • Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
    • Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
    • Alkaline phosphatase ≤ 2.5 x ULN
    • Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m\^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
  8. Cancer antigen (CA)19-9 \<100 U/mL assessed within 14 days of randomization
  9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)

Exclusion criteria

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
  2. Presence of or history of metastatic pancreatic adenocarcinoma
  3. Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
  4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
  5. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
  6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients

  7. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:

    1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
    2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
    3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
866 participants (actual)

Study arms

  • Experimental
    nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2

    Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

    Drug: nab-Paclitaxel · Drug: Gemcitabine

  • Active comparator
    Gemcitabine 1000 mg/m^2

    Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

    Drug: Gemcitabine

Interventions

  • Drugnab-Paclitaxel

    nab-Paclitaxel 125 mg/m\^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.

    Also known as: Abraxane

  • DrugGemcitabine

    Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.

    Also known as: Gemzar

06

What researchers measure

Primary outcomes

  1. Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

    Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.

    Time frame: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone

Secondary outcomes

  1. Kaplan Meier Estimate of Overall Survival (OS)

    Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.

    Time frame: From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone

  2. Number of Participants With Treatment Emergent Adverse Events (TEAE's)

    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: From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).

  3. The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

    The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).

    Time frame: From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).

07

Results

Posted Jan 6, 2020

Participant flow

The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US.

Pre-Treatment (Randomization) Period
Participant flow — Pre-Treatment (Randomization) Period
MilestoneNab-Paclitaxel and GemcitabineGemcitabine
Started432434
Completed429423
Not completed311
Withdrew: Protocol deviation02
Withdrew: Withdrawal by subject29
Withdrew: Adverse event10
Treatment Period
Participant flow — Treatment Period
MilestoneNab-Paclitaxel and GemcitabineGemcitabine
Started429423
Completed287310
Not completed142113
Withdrew: Adverse event7137
Withdrew: Withdrawal by subject3627
Withdrew: Death13
Withdrew: Protocol deviation01
Withdrew: Physician decision54
Withdrew: Disease relapse2838
Withdrew: Other reasons13

Outcome measures

PrimaryKaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.

Time frame:
Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
Reported as:
Median · months
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
monthsNab-Paclitaxel and GemcitabineGemcitabine
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee19.4 (16.62 to 21.91)18.8 (13.83 to 20.30)
Statistical analysis
  • Nab-Paclitaxel and Gemcitabine vs Gemcitabine · Log Rank · p = 0.1824 · Hazard ratio (hr): 0.88 · 95% CI 0.729 to 1.063Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).
SecondaryKaplan Meier Estimate of Overall Survival (OS)

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.

Time frame:
From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone
Reported as:
Median · months
Kaplan Meier Estimate of Overall Survival (OS)
monthsNab-Paclitaxel and GemcitabineGemcitabine
25th Quartile20.7 (19.38 to 22.83)17.7 (14.78 to 19.91)
50th Quartile41.8 (35.55 to 47.28)37.7 (31.11 to 40.51)
75th Quartile90.2 (83.55 to NA)83.0 (61.93 to NA)
Statistical analysis
  • Nab-Paclitaxel and Gemcitabine vs Gemcitabine · Log Rank · p = 0.0128 · Hazard ratio (hr): 0.81 · 95% CI 0.691 to 0.957Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAE's)

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:
From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
ParticipantsNab-Paclitaxel and GemcitabineGemcitabine
≥1 TEAE429417
≥1 Related TEAE423399
≥1 TEAE of Severity Grade 3 or Higher371286
≥ 1 Related TEAE of Severity Grade 3 or Higher332239
≥1 Serious TEAE17696
≥1 Serious Related TEAE10255
≥1 TEAE Leading to Withdrawal of IP11743
≥1 Related TEAE Leading to Withdrawal of IP9835
≥1 TEAE Lead Dose Reduction: nab-Paclitaxel or Gem276210
≥1 Related TEAE Dose Reduct: nab-Paclitaxel or Gem270205
TEAE Lead Dose Interruption nab-Paclitaxel or Gem266158
≥1 Related TEAE Dose Interruption to IP221125
TEAE Leading to Death22
>=1 Related TEAE Leading to Death22
SecondaryThe Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).

Time frame:
From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).
Reported as:
Count of participants · Participants
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
ParticipantsNab-Paclitaxel and GemcitabineGemcitabine
Alkaline phosphatase73
Alanine aminotransferase93
Aspartate aminotransferase92
Bilirubin01

Adverse events

Collected over Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nab-Paclitaxel and Gemcitabine285/432 (66%)181/429 (42.2%)426/429 (99.3%)
Gemcitabine297/434 (68.4%)96/423 (22.7%)407/423 (96.2%)
Most frequent serious events
Showing 10 of 216
Most frequent serious events
EventNab-Paclitaxel and GemcitabineGemcitabine
PyrexiaGeneral disorders29/42924/423
Febrile neutropeniaBlood and lymphatic system disorders16/4293/423
AnaemiaBlood and lymphatic system disorders12/4296/423
DiarrhoeaGastrointestinal disorders12/4290/423
SepsisInfections and infestations12/4295/423
InfectionInfections and infestations9/4291/423
PneumoniaInfections and infestations9/4296/423
VomitingGastrointestinal disorders8/4290/423
CellulitisInfections and infestations8/4295/423
DehydrationMetabolism and nutrition disorders8/4292/423
Most frequent other events
Showing 10 of 55
Most frequent other events
EventNab-Paclitaxel and GemcitabineGemcitabine
NeutropeniaBlood and lymphatic system disorders263/429230/423
AlopeciaSkin and subcutaneous tissue disorders252/42952/423
DiarrhoeaGastrointestinal disorders242/429125/423
FatigueGeneral disorders233/429203/423
NauseaGastrointestinal disorders231/429192/423
AnaemiaBlood and lymphatic system disorders179/429142/423
PyrexiaGeneral disorders171/429115/423
Oedema peripheralGeneral disorders162/429108/423
Peripheral sensory neuropathyNervous system disorders144/42916/423
Decreased appetiteMetabolism and nutrition disorders143/42984/423

Baseline characteristics

The Intent-to-treat (ITT) population consisted of all randomized participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments collected.

Age, Continuous
Age, Continuous(Years)Nab-Paclitaxel and GemcitabineGemcitabineTotal
Mean63.4 ± 9.5862.9 ± 8.8463.2 ± 9.21
Sex: Female, Male
Sex: Female, Male(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
Female204181385
Male228253481
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
Hispanic or Latino111526
Not Hispanic or Latino400393793
Unknown or Not Reported212647
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
American Indian or Alaska Native011
Asian6056116
Black or African American4812
Native Hawaiian or Other Pacific Islander022
White333339672
Other11617
Not Collected or Reported242246
Region of Enrollment
Region of Enrollment(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
North America144156300
Europe203205408
Australia302050
Asia Pacific5553108
Body Surface Area (BSA)
Body Surface Area (BSA)(m²)Nab-Paclitaxel and GemcitabineGemcitabineTotal
Mean1.77 ± 0.2261.78 ± 0.2211.78 ± 0.224
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
0 = Fully Active252268520
1 = Restricted but Ambulatory180166346
2 = Ambulatory but Unable to Work000
3 = Limited Self-care000
4 = Completely Disabled000
Physician Assessment of Peripheral Neuropathy
Physician Assessment of Peripheral Neuropathy(Participants)Nab-Paclitaxel and GemcitabineGemcitabineTotal
Grade 0404408812
Grade 1262147
Grade 2011
Grade 3000
Grade 4000
Missing246

4 further baseline measures are reported on the registry.

08

Study locations

341 sites
  • Local Institution - 043
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic - Arizona
    Scottsdale, Arizona 85259, United States
  • UCSD Moores Cancer Center
    La Jolla, California 92093, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Local Institution - 044
    Sacramento, California 95817, United States
  • UC Davis Cancer Center
    Sacramento, California 95817, United States
  • Local Institution - 001
    San Francisco, California 94110, United States
  • University of California, San Francisco Cutaneous Oncology and Melanoma Center
    San Francisco, California 9411, United States
  • University of California Los Angeles
    Santa Monica, California 90404, United States
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • Local Institution - 059
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers, LLP [Denver-Midtown]
    Denver, Colorado 80218, United States
  • Yale Cancer Center
    New Haven, Connecticut 06510, United States
  • Local Institution - 022
    Boca Raton, Florida 33486, United States
  • Lynn Cancer Institute
    Boca Raton, Florida 33486, United States
  • Florida Cancer Institute Cancer Spec
    Fort Myers, Florida 33916, United States
  • Local Institution - 031
    Fort Myers, Florida 33916, United States
  • Gainesville Heme Oncology Associates
    Gainesville, Florida 32605, United States
  • Local Institution - 011
    Gainesville, Florida 32610, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • University of Miami and Sylvester Cancer Center
    Miami, Florida 33136, United States
  • Florida Hospital Cancer Institute
    Orlando, Florida 32804, United States
  • Local Institution - 039
    Orlando, Florida 32804, United States
  • H Lee Moffitt Cancer Center
    Tampa, Florida 32207, United States
  • Georgia Cancer Specialist
    Atlanta, Georgia 30341, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Northshore University Healthsystem Research Institute
    Evanston, Illinois 60201, United States
  • Illinois Cancer Specialists
    Niles, Illinois 60714, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121-2483, United States
  • Ochsner Medical Center - Jefferson Highway
    New Orleans, Louisiana 70121-2483, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel-Deaconess Medical Center
    Boston, Massachusetts 02115, United States
  • Local Institution - 040
    Boston, Massachusetts 02115, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Local Institution - 045
    Boston, Massachusetts 02215, United States
  • Local Institution - 036
    Ann Arbor, Michigan 48109, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Center Wayne State University
    Detroit, Michigan 48201, United States
  • Local Institution - 021
    Rochester, Minnesota 55905, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Local Institution - 048
    Omaha, Nebraska 68114, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Local Institution - 064
    Basking Ridge, New Jersey 07920, United States
  • MSKCC Basking Ridge
    Basking Ridge, New Jersey 07920, United States
  • Saint Barnabas Medical Center
    Livingston, New Jersey 07039, United States
  • Local Institution - 025
    Buffalo, New York 14263, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Memorial Sloan-Kettering Cancer Center
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Cancer Center West Harrison
    Harrison, New York 10604, United States
  • NYU Langone Medical Center
    Lake Success, New York 11042, United States
  • Local Institution - 008
    New York, New York 10021-6007, United States
  • Memorial Sloan-Kettering Cancer Center - NYC
    New York, New York 10021-6007, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Local Institution - 032
    New York, New York 10032, United States
  • Local Institution - 013
    Rochester, New York 14642, United States
  • University of Rochester Cancer Center, James P. Wilmot Cancer Center
    Rochester, New York 14642, United States
  • Local Institution - 066
    Rockville Center, New York 11570, United States
  • MSKCC at Mercy Medical Center Mercy RockvilleCenter
    Rockville Center, New York 11570, United States
  • MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow
    Sleepy Hollow, New York 10591, United States
  • State University of New York Upstate Medical Center
    Syracuse, New York 13215, United States
  • Local Institution - 051
    Winston-Salem, North Carolina 27157-1082, United States
  • Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1082, United States
  • Local Institution - 030
    Cincinnati, Ohio 45242, United States
  • Oncology Hematology Care, Inc.
    Cincinnati, Ohio 45242, United States
  • University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center
    Cincinnati, Ohio 45267-0501, United States
  • Case Western Reserve Center
    Cleveland, Ohio 44106, United States
  • Local Institution - 047
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic - Taussig Cancer Institute
    Cleveland, Ohio 44195, United States
  • Cleveland Clinic Foundation IRB
    Cleveland, Ohio 44195, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Local Institution - 020
    Cleveland, Ohio 44195, United States
  • Local Institution - 054
    Cleveland, Ohio 44195, United States
  • Local Institution - 005
    Columbus, Ohio 43210, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Local Institution - 049
    Oklahoma City, Oklahoma 73104, United States
  • University of Oklahoma Peggy and Charles Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
  • Local Institution - 019
    Portland, Oregon 97239, United States
  • Oregon Health and Science University OHSU
    Portland, Oregon 97239, United States
  • Local Institution - 016
    Philadelphia, Pennsylvania 19107, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Local Institution - 027
    Pittsburgh, Pennsylvania 15232, United States
  • UPMC Cancer Pavillion
    Pittsburgh, Pennsylvania 15232, United States
  • Chattanooga Oncology Hematology Care
    Chattanooga, Tennessee 37404, United States
  • Local Institution - 023
    Chattanooga, Tennessee 37404, United States
  • Local Institution - 004
    Nashville, Tennessee 37203, United States
  • Sarah Cannon Research Inst
    Nashville, Tennessee 37203, United States
  • Local Institution - 002
    Nashville, Tennessee 37232-6307, United States
  • Vanderbilt- Ingram Cancer Center
    Nashville, Tennessee 37232-6307, United States
  • Texas Oncology
    Dallas, Texas 75230, United States
  • Baylor Sammons Cancer Center
    Dallas, Texas 75246, United States
  • Local Institution - 062
    Dallas, Texas 75246, United States
  • Local Institution - 010
    Dallas, Texas 75390, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Local Institution - 050
    Fort Worth, Texas 76104, United States
  • The Center for Cancer and Blood Disorders - Fort Worth
    Fort Worth, Texas 76104, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Local Institution - 041
    Houston, Texas 77030, United States
  • Texas Oncology, P.A. - Tyler
    Tyler, Texas 75702, United States

Showing the first 100 of 341 sites across 21 countries.

09

References and documents

Publications

  • Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22. PubMed 29932294 ↗
  • Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24. PubMed 30149366 ↗
  • Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3. PubMed 30497432 ↗
  • Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15. PubMed 30768369 ↗
  • Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3. PubMed 33813673 ↗

Study documents

  • Study protocol · Sep 3, 2019
  • Statistical analysis plan · Jan 17, 2019

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01964430
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Oct 17, 2013
Start date
Mar 28, 2014
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Results posted
Jan 6, 2020
Last update
Jun 28, 2023

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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