Malignant GliomaPhase 3NCT01167322
Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
A Phase 3 study testing NPC-07 for oral administration in people with Malignant Glioma, run by Nobelpharma at 3 sites in Japan.
Trial summary
The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- NPC-07 for oral administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesJapan
- Study dates
- Aug 2010to Dec 2011
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years.
- Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV).
- Indication for surgical tumor resection.
- Karnofsky Performance Score of 60 or higher.
- Provides signed informed consent prior to any study procedures.
- Comply with visit schedule and other rules for patients in study protocol.
Who cannot join
- Porphyria, hypersensitivity to porphyrins.
- Renal insufficiency: Creatinine 2.0 mg/dL or higher
- Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher
- Chemotherapy or other treatment for other malignant tumors
- Females who are pregnant or potentially childbearing or are breastfeeding
- Participation in other clinical trial in the previous 1 month
- Ineligible patient based on the judgement of the investigator.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
International Medical Center, Saitama Medical University
Hidaka, Saitama, 350-1298
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
About this study
Official title: Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)
The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV).
Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II.
- Conditions
- Malignant Glioma
- Being tested
- NPC-07 for oral administration
- Keywords
- NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-07 for oral administrationDrug
Also called 5-ALA, 5-aminolevulic acid hydrochloride
NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| NPC-07 | Experimental | Single administration of NPC-07 at a dose of 20mg/kg body weight Receives: Drug: NPC-07 for oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of tissue fluorescence
Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.
Measured: 1 day
Secondary outcomes (7)
Quality of fluorescent tissue
Quality of fluorescent tissue by the judgement of the investigator
Measured: 1 day
Positive predictive value of tissue fluorescence in each biopsy tissue sample
Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among all biopsies taken from areas of strong and weak fluorescence.
Measured: 1 day
Percentage of patients without residual tumor
Percentage of patients without residual tumor in the MRI within 72 hours after surgery
Measured: 3 days
Positive predictive value of non-fluorescent tissue at the biopsy level
Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among the non-fluorescent tissue adjacent to fluorescent tissue areas and the tumor distant cortex with respect to tumor (if available).
Measured: 1 day
Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).
Sensitivity as percentage of actual positives(True positive fraction/True positive fraction + False negative fraction)and specificity as percentage of actual negatives of fluorescence detection (True negative fraction/False positive fraction + True negative fraction) at the biopsy level (if available).
Measured: 1 day
Safety
AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2
Measured: 28 days
Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）
Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soichiro Shibui, MD, PhD, Study director, Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167322
- Sponsor's protocol ID
- NPC-07-1
- Status last verified
- Apr 2012
- First submitted
- 16 Jul 2010
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)
- ClinicalTrials.gov ID
- NCT01167322
- Acronym / sponsor ID
- NPC-07-1
- Conditions
- Malignant Glioma
- Keywords
- NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jul 2010 (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 aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV).
Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-07 | Experimental | Drug: NPC-07 for oral administrationSingle administration of NPC-07 at a dose of 20mg/kg body weight |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years.
- Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV).
- Indication for surgical tumor resection.
- Karnofsky Performance Score of 60 or higher.
- Provides signed informed consent prior to any study procedures.
Key exclusion criteria (7 listed)
- Porphyria, hypersensitivity to porphyrins.
- Renal insufficiency: Creatinine 2.0 mg/dL or higher
- Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher
- Chemotherapy or other treatment for other malignant tumors
- Females who are pregnant or potentially childbearing or are breastfeeding
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-07 for oral administrationAlso: 5-ALA, 5-aminolevulic acid hydrochlorideNPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight. | Drug | NPC-07 |
Primary outcome
Positive predictive value of tissue fluorescence
Time frame: 1 day
Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.
7 secondary outcomes
Quality of fluorescent tissue
Time frame: 1 day
Positive predictive value of tissue fluorescence in each biopsy tissue sample
Time frame: 1 day
Percentage of patients without residual tumor
Time frame: 3 days
Positive predictive value of non-fluorescent tissue at the biopsy level
Time frame: 1 day
Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).
Time frame: 1 day
Safety
Time frame: 28 days
Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）
Time frame: 2 days
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 27 Apr 2012.
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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.
Soichiro Shibui, MD, PhD study director
Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-07 for oral administration in people with Malignant Glioma, run by Nobelpharma at 3 sites 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 6 inclusion and 7 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Positive predictive value of tissue fluorescence (time frame: 1 day). 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 27 Apr 2012.