Clinical trial · Interventional
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
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.
NCT00919737CI-TRIAL-00012497completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NPC-08 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NPC-08
- interventionNames
- Drug: NPC-08
Primary outcomes (1)
- measure
- Overall survival to 12 months
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.