Malignant GliomaPhase 1/2NCT00919737
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
A Phase 1/2 study testing NPC-08 in people with Malignant Glioma, run by Nobelpharma at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- NPC-08
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2009to Apr 2011
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged between 18 and 65 years;
- Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
- Karnofsky Performance Score of 60 or higher;
- Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;
Who cannot join
- More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
- Prior radiotherapy to the brain;
- Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
- Known hypersensitivity to nitrosoureas;
- Participation in any other investigational protocol in the previous 6 months for any type of malignancy;
Trial locations and contacts
1 site in 1 country.
Japan1 site
The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Osaka, Osaka
About this study
Official title: A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.
The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.
- Conditions
- Malignant Glioma
- Being tested
- NPC-08
- Keywords
- NPC-08, carmustine, nitrosourea, safety
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-08Drug
Polifeprosan 20 with Carmustine 3.85%
| Study group | Role | What they receive |
|---|---|---|
| NPC-08 | Experimental | Not described Receives: Drug: NPC-08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival to 12 months
Measured: 12 months
Secondary outcomes (1)
Progression-free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masao Mastutani, M.D., D.M.Sci., Study director, Saitama International Medical Center, Saitama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919737
- Sponsor's protocol ID
- NPC-08-1
- Status last verified
- Oct 2013
- First submitted
- 10 Jun 2009
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT00919737
- Acronym / sponsor ID
- NPC-08-1
- Conditions
- Malignant Glioma
- Keywords
- NPC-08, carmustine, nitrosourea, safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 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 evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-08 | Experimental | Drug: NPC-08 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged between 18 and 65 years;
- Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
- Karnofsky Performance Score of 60 or higher;
- Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;
Key exclusion criteria (5 listed)
- More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
- Prior radiotherapy to the brain;
- Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
- Known hypersensitivity to nitrosoureas;
- Participation in any other investigational protocol in the previous 6 months for any type of malignancy;
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 |
|---|---|---|
| NPC-08Polifeprosan 20 with Carmustine 3.85% | Drug | NPC-08 |
Primary outcome
Overall survival to 12 months
Time frame: 12 months
1 secondary outcome
Progression-free survival
Time frame: 12 months
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 30 Oct 2013.
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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.
Masao Mastutani, M.D., D.M.Sci. study director
Saitama International Medical Center, Saitama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NPC-08 in people with Malignant Glioma, run by Nobelpharma at 1 site in Japan.
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 4 inclusion and 5 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 30 Oct 2013. 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 Japan. 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?
Overall survival to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2013.