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CompletedNCT00919737Updated Oct 30, 2013

Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme

A Phase 1/2 interventional study of NPC-08 in Malignant Glioma, sponsored by Nobelpharma. Completed at 1 site in Japan. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-10-30.

Sponsored by Nobelpharma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Glioma

Keywords

  • NPC-08
  • carmustine
  • nitrosourea
  • safety
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.

This study's enrollment of 24 is below the median of 36 across 1,617 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Nobelpharma is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    NPC-08

    Drug: NPC-08

Interventions

  • DrugNPC-08

    Polifeprosan 20 with Carmustine 3.85%

06

What researchers measure

Primary outcomes

  1. Overall survival to 12 months

    Time frame: 12 months

Secondary outcomes

  1. Progression-free survival

    Time frame: 12 months

07

Study locations

1 site
  • The Tazuke Kofukai Foundation Medical Research Kitano Hospital
    Osaka, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00919737
Lead sponsor
Nobelpharma
Responsible party
Sponsor
First posted
Jun 12, 2009
Start date
Jun 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Oct 30, 2013

Study contacts

Masao Mastutani, M.D., D.M.Sci.
study director · Saitama International Medical Center, Saitama Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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