Locally Advanced and Metastatic Pancreatic CancerPhase 1/2NCT00910741
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
A Phase 1/2 study testing Nanoplatin (NC-6004) and Gemcitabine in people with Locally Advanced and Metastatic Pancreatic Cancer, run by NanoCarrier Co., Ltd. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Locally Advanced and Metastatic Pancreatic Cancer
- What is being tested?
- Nanoplatin (NC-6004) and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2009to Jul 2013
- Phase
- Phase 1/2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chemo-naive, advanced pancreatic cancer
- Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
Who cannot join
- Pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Severe drug hypersensitivity
- Metastasis to the central nervous system and brain
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Taiwan4 sites
Natinal Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veteran General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
- Being tested
- Nanoplatin (NC-6004) and Gemcitabine
- Keywords
- pancreatic cancer, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoplatin (NC-6004) and GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nanoplatin | Experimental | Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc.
Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004). Receives: Drug: Nanoplatin (NC-6004) and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT and Response rate
Measured: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment
Secondary outcomes (1)
Overall survival
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2013
- Study completionJul 2013
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 Locally Advanced and Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoCarrier Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Wu-Chou Su, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910741
- Sponsor's protocol ID
- NC-6004-002
- Status last verified
- Jan 2014
- First submitted
- 29 May 2009
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772.
PubMed 16222314
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
- ClinicalTrials.gov ID
- NCT00910741
- Acronym / sponsor ID
- NC-6004-002
- Keywords
- pancreatic cancer, Gemcitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NanoCarrier Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Study start
- May 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Jun 2009 (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 recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanoplatin | Experimental | Drug: Nanoplatin (NC-6004) and GemcitabineNanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc. Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chemo-naive, advanced pancreatic cancer
- Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
Key exclusion criteria (4 listed)
- Pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Severe drug hypersensitivity
- Metastasis to the central nervous system and brain
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 |
|---|---|---|
| Nanoplatin (NC-6004) and Gemcitabine | Drug | Nanoplatin |
Primary outcome
Incidence of DLT and Response rate
Time frame: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment
1 secondary outcome
Overall survival
Time frame: 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Background: PubMed 16222314Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772.
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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.
Wu-Chou Su, MD principal investigator
National Cheng-Kung University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nanoplatin (NC-6004) and Gemcitabine in people with Locally Advanced and Metastatic Pancreatic Cancer, run by NanoCarrier Co., Ltd. at 5 sites in 2 countries.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan, Singapore. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of DLT and Response rate (time frame: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment). 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 NCT00910741, 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 9 Jan 2014.