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.

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2013-003398-91-CZ
• Date of registration: 03/03/2014
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: 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.
• Scientific title: 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: 15/05/2014
• Target sample size: 800
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003398-91
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; 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: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, New Zealand, Portugal, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

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: 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. PT or 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 metho
Exclusion criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Prior neo-adjuvant treatment, or radiation therapy, or systemic therapy for pancreatic adenocarcinoma

2. Presence of or history of metastatic 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 dat

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects With Surgically Resected Pancreatic Adenocarcinoma
MedDRA version: 20.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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-

Primary Outcome(s)

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

Primary end point(s): The primary efficacy endpoint will be DFS which is defined as the time from the date of randomization to the date of disease recurrence or death, whichever is earlier.

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

Main Objective: To compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone

Secondary Outcome(s)

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

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.

Secondary ID(s)

ABI-007-PANC-003

Source(s) of Monetary Support

Celgene Corporation

Ethics review

Status: Approved
Approval date:
Contact: