Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.