Advanced Pancreatic CancerPhase 2NAPSPACNCT02124317
Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing nanoparticle albumin-bound paclitaxel and S-1 in people with Advanced Pancreatic Cancer, run by Chinese PLA General Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- nanoparticle albumin-bound paclitaxel and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Other malignancy within 5 years.
- Can't be followed up or obey protocol.
- Ineligible by the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
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).
Read the detailed 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- nanoparticle albumin-bound paclitaxel, S-1
- Keywords
- nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer, objective response rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticle albumin-bound paclitaxelDrug
Also called nab-paclitaxel, Abraxane, ABI-007
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-1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: nanoparticle albumin-bound paclitaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: Measure at every 6 weeks (every 2 cycles)
Secondary outcomes (4)
Progression-free survival
Measure of time from study treatment to disease progression or death.
Measured: up to 15 months
Overall survival
Measure of time from study treatment to patient's death or lost to follow-up.
Measured: up to 2 years
Disease control rate
The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: Measure every 6 weeks (every 2 cycles)
Safety and tolerability
Percentage of patients who experience adverse events during this study.
Measured: up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
- Investigators
- Guanghai Dai, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124317
- Sponsor's protocol ID
- ABXS001
- Acronym
- NAPSPAC
- Status last verified
- Dec 2016
- First submitted
- 24 Apr 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29190925
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02124317
- Acronym / sponsor ID
- NAPSPAC / ABXS001
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer, objective response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanoparticle albumin-bound paclitaxel, S-1 | Experimental | Drug: nanoparticle albumin-bound paclitaxel, Drug: S-1nanoparticle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nanoparticle albumin-bound paclitaxelAlso: nab-paclitaxel, Abraxane, ABI-007nanoparticle 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. | Drug | nanoparticle albumin-bound paclitaxel, S-1 |
| S-1S-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. | Drug | nanoparticle albumin-bound paclitaxel, S-1 |
Primary outcome
Objective response rate
Time frame: Measure at every 6 weeks (every 2 cycles)
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
4 secondary outcomes
Progression-free survival
Time frame: up to 15 months
Overall survival
Time frame: up to 2 years
Disease control rate
Time frame: Measure every 6 weeks (every 2 cycles)
Safety and tolerability
Time frame: up to 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Derived from this study: PubMed 29190925Shi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghai Dai principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nanoparticle albumin-bound paclitaxel and S-1 in people with Advanced Pancreatic Cancer, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Measure at every 6 weeks (every 2 cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02124317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.