Advanced Pancreatic CancerPhase 2NAPGAPNCT02135822
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
A Phase 2 study testing nanoparticle albumin-bound paclitaxel and gemcitabine 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma. 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 gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2015
- 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.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Rong Liu
About this study
Official title: Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
Read the detailed description
Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS). Gemcitabine is the only approved single agent. Gemcitabine-based chemotherapy did not show benefit in OS during the past decade. The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients. This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- nanoparticle albumin-bound paclitaxel, gemcitabine
- Keywords
- nanoparticle albumin-bound paclitaxel, gemcitabine, advanced pancreatic cancer
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.
gemcitabineDrug
Also called Gemzar
Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| nanoparticle albumin-bound paclitaxel, gemcitabine | Experimental | Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle. Number of cycle: 6 cycles. Receives: Drug: nanoparticle albumin-bound paclitaxel; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall 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) up to 18 weeks
Secondary outcomes (4)
Progression-free survival
Measurement of time from study treatment to disease progression or death.
Measured: up to 15 months
Overall survival
Measurement 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) up to 18 weeks
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 posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu, Rong, Chinese PLA General Hospital
- Investigators
- Rong Liu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135822
- Sponsor's protocol ID
- ABX-LR001
- Acronym
- NAPGAP
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu R, Yu X, Hao J, Wang L, Pan H, Han G, Xu J, Zhang Y, Yang S, Chen J, Ying J, Dai G, Li M, Begic D, Lu B, Shen L. Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study. BMC Cancer. 2017 Dec 22;17(1):885. doi: 10.1186/s12885-017-3887-z.
PubMed 29273007
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02135822
- Acronym / sponsor ID
- NAPGAP / ABX-LR001
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- nanoparticle albumin-bound paclitaxel, gemcitabine, advanced pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 May 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
Detailed description
Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS). Gemcitabine is the only approved single agent. Gemcitabine-based chemotherapy did not show benefit in OS during the past decade. The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients. This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.
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, gemcitabine | Experimental | Drug: nanoparticle albumin-bound paclitaxel, Drug: gemcitabineNanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, 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, gemcitabine |
| gemcitabineAlso: GemzarGemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles. | Drug | nanoparticle albumin-bound paclitaxel, gemcitabine |
Primary outcome
Overall response rate
Time frame: Measure at every 6 weeks (every 2 cycles) up to 18 weeks
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) up to 18 weeks
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 16 May 2014.
- Derived from this study: PubMed 29273007Xu R, Yu X, Hao J, Wang L, Pan H, Han G, Xu J, Zhang Y, Yang S, Chen J, Ying J, Dai G, Li M, Begic D, Lu B, Shen L. Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study. BMC Cancer. 2017 Dec 22;17(1):885. doi: 10.1186/s12885-017-3887-z.
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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.
Rong Liu 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 gemcitabine 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 16 May 2014. 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?
Contact Rong Liu (13801150988, liurong301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Measure at every 6 weeks (every 2 cycles) up to 18 weeks). 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 NCT02135822, 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 16 May 2014.