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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01964430
Recruitment Status : Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : December 10, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Drug: nab-Paclitaxel 125 mg/m2 Drug: gemcitabine 1000 mg/m2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 866 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 28, 2014
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nab-Paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2
Treatment Arm A
Drug: nab-Paclitaxel 125 mg/m2
nab-Paclitaxel 125 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by intravenous (IV) administration, followed by gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of a 28 days cycle by IV administration for a total of 6 cycles
Other Name: Abraxane

Drug: gemcitabine 1000 mg/m2
nab-Paclitaxel 125 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by intravenous (IV) administration, followed by gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of a 28 days cycle by IV administration for a total of 6 cycles
Other Name: Gemzar

Active Comparator: Gemcitabine 1000 mg/m2
Treatment Arm B
Drug: gemcitabine 1000 mg/m2
Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles
Other Name: Gemzar

Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: up to approximately 9 months ]
    Time from the date of randomization to the date of disease recurrence or death, whichever is earlier. (Disease recurrence will be determined by independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans.)

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to approximately 18 months ]
    Time from the date of randomization to the date of death

  2. Number of Participants with Adverse Events [ Time Frame: up to approximately 18 months ]
    Assessment based on AEs, SAEs, laboratory abnormalities.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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: 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. Eastern Cooperative Oncology Group (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:

    • 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 (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. 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:

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 ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01964430

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Sponsors and Collaborators
Study Director: Ileana Elias, M.D. Celgene Corporation

Responsible Party: Celgene Identifier: NCT01964430     History of Changes
Other Study ID Numbers: ABI-007-PANC-003
2013-003398-91 ( EudraCT Number )
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Keywords provided by Celgene:
Resectable pancreatic cancer
resectable PDA
surgically resected
Phase 3

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Endocrine Gland Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs