Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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5 April 2021 |
Main ID: |
EUCTR2013-003398-91-AT |
Date of registration:
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03/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A large clinical study, for patients who have recently undergone surgery to remove some cancerous tissue from the pancreas, to compare post surgery treatment using nab-Paclitaxel and Gemcitibine or Gemcitibine alone.
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Scientific title:
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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 |
Date of first enrolment:
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16/04/2014 |
Target sample size:
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800 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003398-91 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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Czechia
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Denmark
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Finland
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France
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Germany
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Hong Kong
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Hungary
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Ireland
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Italy
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Korea, Republic of
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Netherlands
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New Zealand
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Portugal
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Singapore
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Spain
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Sweden
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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ClinicalTrialDisclosure
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Address:
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86 Morris Avenue
07901
New Jersey
United States |
Telephone:
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+1 913-709-6862 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Name:
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ClinicalTrialDisclosure
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Address:
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86 Morris Avenue
07901
New Jersey
United States |
Telephone:
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+1 913-709-6862 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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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 staging: T 1-3, N0-1, M0.
3. Subject should be able to start treatment no later than 12 weeks postsurgery.
4. Male or non-pregnant, non-lactating females who are =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 m2. 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 (eg. PTor INR 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 (ß -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.
* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria: The presence of any of the following will exclude a subject from enrollment:
1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
2. Presence of or history ofmetastatic or locally recurrent 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 history of human immunodeficiency virus (HIV) infection, or known history of active hepatitis B or C and are currently serologically positive with evidence of prior or signs of active chronic hepatitis
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
d. Peripheral neuropathy > grade 2
e. Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Subjects With Surgically Resected Pancreatic Adenocarcinoma MedDRA version: 21.0
Level: LLT
Classification code 10033602
Term: Pancreatic adenocarcinoma resectable
System Organ Class: 100000004864
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Intervention(s)
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Trade Name: Abraxane Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-
Trade Name: Gemcitabine for Injection 1g Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
Trade Name: Gemcitabine 38mg/ml powder for solution for infusion Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
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Primary Outcome(s)
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Primary end point(s): The primary efficacy endpoint will be DFS, determined by an independent radiologist(s) who is blinded to the treatment assignment, which is defined as the time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
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Secondary Objective: -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
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Main Objective: To compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone
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Timepoint(s) of evaluation of this end point: Disease recurrence will be determined by the independent radiological review of CT or MRI scans. Subjects who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death will be censored. Detailed censoring rules will be documented in the SAP. The survival distribution of DFS will be estimated using the Kaplan-Meier method
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Secondary Outcome(s)
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Secondary end point(s): The secondary efficacy endpoint will be OS which is defined as the time from the date of randomization to the date of death.
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Timepoint(s) of evaluation of this end point: Subjects who are alive will be censored on the last-known-to be- alive date.
The survival distribution of OS will be estimated using the Kaplan-Meier method
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Secondary ID(s)
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2013-003398-91-CZ
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ABI-007-PANC-003
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Source(s) of Monetary Support
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Celgene Corporation
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Ethics review
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Status: Approved
Approval date: 10/04/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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