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Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426281
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Joon Oh Park, Samsung Medical Center

Brief Summary:
Nab-paclitaxel (interchangeable with ABRAXANE and ABI-007) is a unique protein formulation of a noncrystalline, amorphous form of paclitaxel in an insoluble particle state. Nab-paclitaxel was designed to improve the chemotherapeutic effects of paclitaxel by exploiting endogenous transport pathways to deliver higher doses of paclitaxel to the tumor and to reduce the solvent-related hypersensitivity and other toxicities associated with Taxol® (paclitaxel) injections, the solvent Cremophor EL, and ethanol vehicle. Nab-paclitaxel provides more rapid tissue distribution and increased tumor accumulation compared to cremophor-EL paclitaxel. Mechanistically, albumin receptor-mediated transport across the endothelium, binding to interstitial proteins, and macropinocytic or receptor-mediated uptake into tumor cells as well as sequestration of paclitaxel by cremophor-EL may contribute to the observed differences. Furthermore, nab-paclitaxel synergizes with gemcitabine in preclinical models. The Cremophor EL-free medium enables nab-paclitaxel to be given at a higher dose and in a shorter duration without the need for premedication to prevent solvent-related hypersensitivity reactions. As of March 2014, nab-paclitaxel is approved under the trade name of ABRAXANE in over 45 countries/regions, including the US, Canada, India, European Union/European Economic Area, South Korea, China, Australia, Bhutan, United Arab Emirates, Nepal, New Zealand, Japan, Russia, Sri Lanka, Argentina, Hong Kong, and Lebanon for the treatment of patients with metastatic breast cancer. ABRAXANE is also approved for the first-line treatment of locally advanced or metastatic non small cell lung cancer (NSCLC) in the US, Japan, Argentina, Australia, and New Zealand, for treatment of advanced gastric cancer in Japan, and for first-line treatment of metastatic adenocarcinoma of the pancreas in the US, EU/EEA, Australia, New Zealand and Argentina.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: nab-paclitaxel Drug: gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Safety and Efficacy of Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : June 4, 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nab-paclitaxel in combination with gemcitabine
nab-paclitaxel in combination with gemcitabine nab- paclitaxel 125mg/m2 in combination with gemcitabine 1000mg/m2 D1, 8 15 every 4 weeks.
Drug: nab-paclitaxel
nab- paclitaxel 125mg/m2 D1, 8 15 every 4 weeks.
Other Names:
  • ABRAXANE
  • ABI-007

Drug: gemcitabine
gemcitabine 1000mg/m2 D1, 8 15 every 4 weeks.




Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 4 months ]
    The primary endpoint of the study is progression-free survival (PFS) defined as time to progression or death, whichever comes first.


Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 4 months ]
    Survival will be measured as the time from the day 1 of first chemotherapy to the date of death.

  2. Response rate [ Time Frame: 4 months ]
    Percentage of response is complete response (CR) or partial response (PR) is defined as the period is maintained.

  3. Disease control rate [ Time Frame: 4 months ]
    Percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents

  4. toxicities (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) [ Time Frame: 4 months ]
    Toxicities as measured by Adverse Events(AEs) and Laboratory Results . The severity / intensity of AEs will be graded based upon the subject's symptoms according to the current active minor version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)


Other Outcome Measures:
  1. Tumor Markers (CA19-9 test) [ Time Frame: 4 months ]
    Tumor Markers as measured by CA19-9 test.

  2. Quality of life questionnaire [ Time Frame: 4 months ]
    Quality of life will be evaluated for nab-paclitaxel in combination with gemcitabine using the EORTC-QLQ-30 and EORTC QLQ- PAN26 questionnaires.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (Islet cell neoplasms or neuroendocrine carcinomas are excluded)
  2. ≥ 18 years of age at the time of signing the informed consent document
  3. ECOG 0-1
  4. At least one measurable lesion according to recist v1.1
  5. No prior palliative chemotherapy for the treatment of metastatic pancreatic cancer (Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed if the treatment had been received at least 6 months before enroll).
  6. Adequate BM function: ANC ≥1.5 × 109/L; Platelet count ≥100,000/mm2 (100 × 109/L); Hb (Hb) ≥9 g/dL.
  7. Adequate liver and renal function (obtained ≤14 days prior to enroll): AST (SGOT), ALT (SGPT) ≤2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤5 × ULN is allowed; Total bilirubin 1.5 ≤ ULN; Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m2
  8. Albumin level ≥ 3 g/dl
  9. Subjects should be asymptomatic for jaundice prior to Cycle 1 Day 1
  10. Subject with signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
  11. Female of childbearing potential (FCBP) (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:

    • Either commit to true abstinence or agree to the use of 2 physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP; and
    • Has a negative serum pregnancy test (β-hCG) result at screening
  12. Male subjects 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
  13. Subject able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Subject has known symptomatic brain metastases.
  2. History of malignancy in the last 5 years.
  3. Breast-feeding or pregnant female
  4. Patients with plastic biliary stent (Metal biliary stents are allowed.)
  5. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  6. Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C.
  7. Subject has undergone major surgery within 4 weeks prior to Cycle 1 Day 1 of treatment in this study.
  8. Subject who experienced a recent myocardial infarction, including severe/unstable angina pectoris, coronary/peripheral artery bypass graft, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, significant or uncontrolled cardiovascular disease CHF, and cerebrovascular accident or transient ischemic attack, or seizure disorder in the past year.
  9. Subject has a history of allergy or hypersensitivity to any of the study drugs
  10. Subjects with history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
  11. Subjects with a history of interstitial lung disease
  12. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the prostate (Gleason score ≤ 7), cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment).
  13. Patients has > Grade 1 pre-existing peripheral neuropathy (per CTCAE)
  14. Subject has 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.
  15. Subject is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
  16. Subject is unwilling or unable to comply with study procedures
  17. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

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 ClinicalTrials.gov identifier (NCT number): NCT02426281


Contacts
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Contact: Park joon oh, MD,Ph.D. 2-3410-3459 ext 82 joonoh.park@samsung.com

Locations
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Korea, Republic of
Samsungj Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: sungu park    82-2-3410-6820      
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Joon Oh Park, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02426281    
Other Study ID Numbers: 2014-10-061
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs