Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer

NCT02124317 | Unknown Phase 2 DMC

• 1 other identifier: ABXS001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Pancreatic Cancer

Keywords

nanoparticle albumin-bound paclitaxel; S-1; advanced pancreatic cancer; objective response rate

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Progression-free survival

  up to 15 months

• Overall survival

  up to 2 years

• Disease control rate

  Measure every 6 weeks (every 2 cycles)

• Safety and tolerability

  up to 18 month

Study Arms (1)

nanoparticle albumin-bound paclitaxel, S-1

EXPERIMENTAL

nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which 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 cycle: 6 cycles.

Drug: nanoparticle albumin-bound paclitaxel; Drug: S-1

Interventions

nanoparticle albumin-bound paclitaxel DRUG

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.

Also known as: nab-paclitaxel, Abraxane, ABI-007

nanoparticle albumin-bound paclitaxel, S-1

S-1 DRUG

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.

nanoparticle albumin-bound paclitaxel, S-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed-consent form.
• Age no less than 18 years.
• Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
• Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
• 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.
• Adequate liver/bone marrow function.
• Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
• Compliant, and can be followed up regularly.

You may not qualify if:

• Pregnant or breast-feeding female, or not willing to take contraception measures during study.
• Serious infection requiring antibiotics intervention during recruitment.
• Allergic to study drug.
• More than grade 1 neuropathy.
• Uncontrolled brain metastasis or mental illness.
• Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
• Other malignancy within 5 years.
• Can't be followed up or obey protocol.
• Ineligible by the discretion of the investigator.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Shi Y, Zhang S, Han Q, Li J, Yan H, Lv Y, Shi H, Liu R, Dai G. Nab-paclitaxel plus S-1 in advanced pancreatic adenocarcinoma (NPSPAC): a single arm, single center, phase II trial. Oncotarget. 2017 Sep 28;8(54):92401-92410. doi: 10.18632/oncotarget.21359. eCollection 2017 Nov 3.

  PMID: 29190925 DERIVED

MeSH Terms

Interventions

Taxes; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; S 1 (combination)

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Guanghai Dai

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chief physician

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

CN (1)