Clinical Trials List
Protocol NumberABI-007-PANC-003
NCT Number(ClinicalTrials.gov Identfier)NCT01964430
2014-11-01 - 2022-02-28
Phase III
Terminated6
ICD-10C25.3
Malignant neoplasm of pancreatic duct
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9157.3
Malignant neoplasm of pancreatic duct
A Phase 3, Multicenter, Open-label, Randomized Study of nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
-
Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
-
Sponsor
Celgene Corporation
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yee Chao Division of Hematology & Oncology
- Ming-Huang Chen Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
- Yi-Ming Shyr Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 何景良 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Li-Tzong Chen Division of General Internal Medicine
- 趙盈瑞 Division of General Surgery
- Chia-Jui Yen Division of Hematology & Oncology
- 李宗達 無
- 李忠達 無
- 蔡宏名 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-Nan Yeh Division of General Surgery
- Wen-Chi Chou 無
- Jen-Shi Chen Division of Hematology & Oncology
- Yung-Chia Kao 無
- Tai-Sen Yeh 無
- Ming-Mo Hou 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Pancreatic Adenocarcinoma
Objectives
Primary Objective
To compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine
alone
Secondary Objectives
To assess overall survival (OS) between subjects randomized to nab-paclitaxel in
combination with gemcitabine and subjects randomized to gemcitabine alone
To assess safety and tolerability of the 2 treatment regimens
Exploratory Objectives
To evaluate tumor markers to assess molecular heterogeneity
To evaluate the effect of nab-paclitaxel in combination with gemcitabine and
gemcitabine alone on subject’s quality of life (QoL)
Test Drug
nab-Paclitaxel
Active Ingredient
Paclitaxel
Dosage Form
unique protein formulation
Dosage
100
Endpoints
Subjects will be assessed by computed tomography (CT) scan performed within 14 days prior to
randomization (during the screening period), every 8 weeks for the first 24 weeks, then every 12
weeks for the first 3 years, and then every 24 weeks thereafter until disease recurrence for up to 5
years from last treatment. Magnetic resonance imaging (MRI) can be used based on the
investigator’s judgment or institution policy, as long as the same modality is used throughout the
study. Subjects who are discontinued from treatment prior to completing the 6 cycles of
treatment in the absence of disease recurrence (eg, subjects discontinued for unacceptable
toxicity or subject/investigator discretion) should undergo repeat imaging until disease
recurrence, death, or the start of new anticancer therapy is documented.
During the study, DFS will be determined by independent radiologist(s) who are blinded to the
treatment assignment. The independent radiologic review will follow a separate imaging charter.
After disease recurrence, subjects will be followed for survival every 12 weeks, or more
frequently as needed, until death, withdrawal of consent, or the study closes, whichever is the
earliest. This evaluation may be made by record review and/or telephone contact.
randomization (during the screening period), every 8 weeks for the first 24 weeks, then every 12
weeks for the first 3 years, and then every 24 weeks thereafter until disease recurrence for up to 5
years from last treatment. Magnetic resonance imaging (MRI) can be used based on the
investigator’s judgment or institution policy, as long as the same modality is used throughout the
study. Subjects who are discontinued from treatment prior to completing the 6 cycles of
treatment in the absence of disease recurrence (eg, subjects discontinued for unacceptable
toxicity or subject/investigator discretion) should undergo repeat imaging until disease
recurrence, death, or the start of new anticancer therapy is documented.
During the study, DFS will be determined by independent radiologist(s) who are blinded to the
treatment assignment. The independent radiologic review will follow a separate imaging charter.
After disease recurrence, subjects will be followed for survival every 12 weeks, or more
frequently as needed, until death, withdrawal of consent, or the study closes, whichever is the
earliest. This evaluation may be made by record review and/or telephone contact.
Inclution Criteria
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
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: T 1-3, N0-1, M0.
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. ECOG performance status of 0 or 1.
6. Acceptable hematology parameters:
Absolute neutrophil count ≥1500 cell/mm3
Platelet count ≥100,000/mm3
Hemoglobin (Hgb) ≥9 g/dL
7. Acceptable blood chemistry levels:
AST/ SGOT and ALT/ SGPT ≤2.5 × upper limit of normal range (ULN)
Total bilirubin ≤ ULN (subjects 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. CA19-9 <100 U/mL assessed within 14 days of randomization
9. Acceptable coagulation studies as demonstrated by PT and PTT within normal limits
(±15%)
10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not
undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy
[the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at
least 24 consecutive months [ie, has had menses at any time during the preceding 24
consecutive months]) must:
Agree to the use of two physician-approved contraceptive methods (oral, injectable,
or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier
contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3
months following the last dose of IP; and
Has negative serum pregnancy test (β -hCG) result at screening
11. Male subjects:
a. Must practice true abstinence
or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential while participating in the study,
during dose interruptions and for 6 months following IP discontinuation, even if he
has undergone a successful vasectomy.
12. Understand and voluntarily sign an ICF prior to any study related assessments or
procedures being conducted.
13. Be able to adhere to the study visit schedule and other protocol requirements.
Subjects must satisfy the following criteria to be enrolled in the study:
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: T 1-3, N0-1, M0.
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. ECOG performance status of 0 or 1.
6. Acceptable hematology parameters:
Absolute neutrophil count ≥1500 cell/mm3
Platelet count ≥100,000/mm3
Hemoglobin (Hgb) ≥9 g/dL
7. Acceptable blood chemistry levels:
AST/ SGOT and ALT/ SGPT ≤2.5 × upper limit of normal range (ULN)
Total bilirubin ≤ ULN (subjects 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. CA19-9 <100 U/mL assessed within 14 days of randomization
9. Acceptable coagulation studies as demonstrated by PT and PTT within normal limits
(±15%)
10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not
undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy
[the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at
least 24 consecutive months [ie, has had menses at any time during the preceding 24
consecutive months]) must:
Agree to the use of two physician-approved contraceptive methods (oral, injectable,
or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier
contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3
months following the last dose of IP; and
Has negative serum pregnancy test (β -hCG) result at screening
11. Male subjects:
a. Must practice true abstinence
or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential while participating in the study,
during dose interruptions and for 6 months following IP discontinuation, even if he
has undergone a successful vasectomy.
12. Understand and voluntarily sign an ICF prior to any study related assessments or
procedures being conducted.
13. Be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
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:
a. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
b. History of interstitial lung disease, slowly progressive dyspnea and unproductive
cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
hypersensitivity pneumonitis or multiple allergies
c. 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 ECG abnormality,
cerebrovascular accident, transient ischemic attack, or seizure disorder
8. Enrollment in any other clinical protocol or investigational study with an interventional
agent or assessments that may interfere with study procedures
9. Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study
10. Any condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study
11. Any condition that confounds the ability to interpret data from the study
12. Unwillingness or inability to comply with study procedures
The presence of any of the following will exclude a subject from enrollment:
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:
a. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
b. History of interstitial lung disease, slowly progressive dyspnea and unproductive
cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
hypersensitivity pneumonitis or multiple allergies
c. 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 ECG abnormality,
cerebrovascular accident, transient ischemic attack, or seizure disorder
8. Enrollment in any other clinical protocol or investigational study with an interventional
agent or assessments that may interfere with study procedures
9. Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study
10. Any condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study
11. Any condition that confounds the ability to interpret data from the study
12. Unwillingness or inability to comply with study procedures
The Estimated Number of Participants
-
Taiwan
70 participants
-
Global
800 participants
