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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Clinicaltrials.gov identifier NCT03929094

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted April 26, 2019

Study Description

Brief summary:

This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.

  • Condition or Disease:Metastatic Pancreatic Cancer
  • Intervention/Treatment: Drug: Paclitaxel for Injection(Albumin Bound)
    Drug: Gemcitabine
  • Phase: Phase 2
Detailed Description

While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) and gemcitabine 1000 mg/m^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: nab-paclitaxel + gemcitabine
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
Drug: Paclitaxel for Injection(Albumin Bound)
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.

Drug: Gemcitabine
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic.
Outcome Measures
  • Primary Outcome Measures: 1. Overall Response Rate [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
  • 2. Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
  • Secondary Outcome Measures: 1. overall survival [ Time Frame: through study completion, an average of 1 year ]
    To evaluate the overall survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
  • 2. adverse events [ Time Frame: through study completion, an average of 1 year ]
    adverse events of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

1. Signed informed content obtained prior to treatment. The patients were fully explained
and understood the purpose, contents, predicted efficacy, pharmacological effects, and
risks of this study.

2. target population

- the patients were confirmed as metastatic pancreatic cancer by histopathology or
cytopathology.

- At least one measurable objective lesion (both primary and metastatic) was
identified based on the RECIST1.1 criteria;

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

- The expected survival after surgery ≥ 3 months

- The subjects have good compliance, can be treated and followed up, and
voluntarily comply with the relevant provisions of this study

- No contraindications for gemcitabine and nab-paclitaxel.

3. Age and reproductive status

- Age ≥ 18 years and ≤ 75 years

- Subjects of child-bearing age must agree to take effective contraceptive measures
during the study period; Serum or urine pregnancy tests must be negative for
women of childbearing age 24 hours before the start of chemotherapy;

- Women must not lactate.

Exclusion Criteria:

1. The target disease has cerebral metastasis;

2. medical history and complications

- patients had uncontrolled serious medical condition that the investigator
considered may affect the subject's to receive treatment under the study program,
For example, patients with severe medical diseases, including severe heart
disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled
hypertension, uncontrolled infection, active peptic ulcer, etc.

- Dementia, changing of mental state or any mental illness which could hinder
understanding or informed consent or fill out questionnaires;

- History of allergy or hypersensitivity to any therapeutic ingredient;

- Combined with other malignant tumors excepted pancreatic cancer within the first
5 years of randomization, excepted well-treated basal cell or squamous cell
carcinoma of the skin, localized prostate cancer after radical resection, and
ductal carcinoma in situ of the breast after radical resection.

- Previously received systemic therapy for advanced/metastatic pancreatic cancer;

- Subjects who had previously been pathologically diagnosed with squamous cell
carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with
taxa regimen.

- Patients who had Grade 2 or above Peripheral neuropathy.

3. Abnormal results of physical examination and laboratory examination

- Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 ×
109/L; Hemoglobin (Hgb) < 90g/L

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/
alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5
× institutional upper limit of normal (ULN), >5 × institutional upper limit of
normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN;

- Creatinine (CRE)> 1.5 × ULN

- Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN.
Unless the subject had received anticoagulant treatment

4. Subjects had hepatitis b surface antigen (HBsAg)-positive and hbv-dna titer in
peripheral blood greater than or equal to 1000 copy number /L;If HBsAg is positive and
the peripheral blood hbv-dna <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects. 5. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients; 6. Patients combined with other anti-tumor drugs. 7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period. 8. The researchers considered that there were other conditions that were not suitable for enrollment.

Contacts and Locations
Contacts

Contact: Xian-Jun Yu, M.D., Ph.D. +86 21 64175590 yuxianjun@fudanpci.org

Locations

China, Shanghai
FUDAN University
Shanghai

Sponsors and Collaborators

Fudan University

CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

Study Director: Xian-Jun Yu Fudan University

More Information
  • Responsible Party: Fudan University
  • ClinicalTrials.gov Identifier: NCT03929094 History of Changes
  • Other Study ID Numbers: CSPAC-22
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: April 26, 2019
  • Last Verified: March 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Pancreatic Neoplasms