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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Malignant Glioma

Treatments: Drug: NPC-07 for oral administration

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167322

NPC-07-1

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

NPC-07

Experimental group

Description:

Single administration of NPC-07 at a dose of 20mg/kg body weight

Treatment:

Drug: NPC-07 for oral administration