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

This study has been completed.
Information provided by (Responsible Party):
Nobelpharma Identifier:
First received: June 10, 2009
Last updated: October 29, 2013
Last verified: October 2013

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.

Condition Intervention Phase
Malignant Glioma
Drug: NPC-08
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Overall survival to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-08 Drug: NPC-08
Polifeprosan 20 with Carmustine 3.85%


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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:

  • 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;
  Contacts and Locations
Please refer to this study by its identifier: NCT00919737

The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Osaka, Japan
Sponsors and Collaborators
Study Director: Masao Mastutani, M.D., D.M.Sci. Saitama International Medical Center, Saitama Medical University
  More Information

No publications provided

Responsible Party: Nobelpharma Identifier: NCT00919737     History of Changes
Other Study ID Numbers: NPC-08-1
Study First Received: June 10, 2009
Last Updated: October 29, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on April 17, 2014