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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02124317
Other study ID # ABXS001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received April 24, 2014
Last updated December 21, 2016
Start date April 2014
Est. completion date May 2017

Study information

Verified date December 2016
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).


Description:

Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date May 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.

6. Adequate liver/bone marrow function.

7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.

8. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Pregnant or breast-feeding female, or not willing to take contraception measures during study.

2. Serious infection requiring antibiotics intervention during recruitment.

3. Allergic to study drug.

4. More than grade 1 neuropathy.

5. Uncontrolled brain metastasis or mental illness.

6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.

7. Other malignancy within 5 years.

8. Can't be followed up or obey protocol.

9. Ineligible by the discretion of the investigator.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
nanoparticle albumin-bound paclitaxel
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Number of cycles: 6 cycles.
S-1
S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST). Measure at every 6 weeks (every 2 cycles) No
Secondary Progression-free survival Measure of time from study treatment to disease progression or death. up to 15 months No
Secondary Overall survival Measure of time from study treatment to patient's death or lost to follow-up. up to 2 years No
Secondary Disease control rate The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST). Measure every 6 weeks (every 2 cycles) No
Secondary Safety and tolerability Percentage of patients who experience adverse events during this study. up to 18 month Yes
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