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Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer (ASAGPAC)

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ClinicalTrials.gov Identifier: NCT03636308
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief Summary:
This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: nanoparticle albumin-bound paclitaxel Drug: S1 Drug: Gemcitabine Phase 2

Detailed Description:
Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021


Arm Intervention/treatment
Experimental: AS:Nanoparticle albumin-bound paclitaxel,S-1

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle.

S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
Other Names:
  • nab-paclitaxel
  • Abraxane
  • ABI-007

Drug: S1
S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

Active Comparator: AG:Nanoparticle albumin-bound paclitaxel,Gemcitabine

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle.

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.

Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
Other Names:
  • nab-paclitaxel
  • Abraxane
  • ABI-007

Drug: Gemcitabine
Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).


Secondary Outcome Measures :
  1. Objective response rate of primary tumor [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

  2. Progression-free survival [ Time Frame: up to 15 months ]
    Measure of time from study treatment to disease progression or death.

  3. Overall survival [ Time Frame: up to 2 years ]
    Measure of time from study treatment to patient's death or lost to follow-up.

  4. Disease control rate [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).

  5. The incidence of treatment related emergent adverse events(Safety and Tolerance) [ Time Frame: Until 28 days after the deadline of enrollment ]
    Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version



Information from the National Library of Medicine

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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. Signed informed-consent form.
  2. Age no less than 18 years.
  3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
  4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
  5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  6. At least 4 weeks since completion of the last operation except for diagnostic biopsy.
  7. At least 4 weeks since completion of radiotherapy to lesions.
  8. Not suitable for local treatment.
  9. Adequate liver/bone marrow function.
  10. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
  11. Compliant, and can be followed up regularly.

Exclusion Criteria:

  1. Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
  3. Serious infection requiring antibiotics intervention during recruitment.
  4. Allergic to study drug.
  5. More than grade 1 neuropathy.
  6. Uncontrolled brain metastasis or mental illness.
  7. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
  8. Other malignancy within 5 years.
  9. Can't be followed up or obey protocol.
  10. Ineligible by the discretion of the investigator.

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): NCT03636308


Contacts
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Contact: Jun Zhou 861088196561 13366152815@126.com

Locations
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China, Beijing
Peking University Cancer Hospital and Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhou, MD         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital

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Responsible Party: Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier: NCT03636308    
Other Study ID Numbers: ASAG01
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
advanced pancreatic cancer
nanoparticle albumin-bound paclitaxel
S-1
gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound 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