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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01167322
Other study ID # NPC-07-1
Secondary ID
Status Completed
Phase Phase 3
First received July 16, 2010
Last updated April 26, 2012
Start date August 2010
Est. completion date December 2011

Study information

Verified date April 2012
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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, ?-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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
NPC-07 for oral administration
NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.

Locations

Country Name City State
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan International Medical Center, Saitama Medical University Hidaka Saitama
Japan Kyorin University Hospital Mitaka Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positive predictive value of tissue fluorescence Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence. 1 day No
Secondary Quality of fluorescent tissue Quality of fluorescent tissue by the judgement of the investigator 1 day No
Secondary Positive predictive value of tissue fluorescence in each biopsy tissue sample Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among all biopsies taken from areas of strong and weak fluorescence. 1 day No
Secondary Percentage of patients without residual tumor Percentage of patients without residual tumor in the MRI within 72 hours after surgery 3 days No
Secondary Positive predictive value of non-fluorescent tissue at the biopsy level Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among the non-fluorescent tissue adjacent to fluorescent tissue areas and the tumor distant cortex with respect to tumor (if available). 1 day No
Secondary Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available). Sensitivity as percentage of actual positives(True positive fraction/True positive fraction + False negative fraction)and specificity as percentage of actual negatives of fluorescence detection (True negative fraction/False positive fraction + True negative fraction) at the biopsy level (if available). 1 day No
Secondary Safety AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2 28 days Yes
Secondary Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2) Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2) 2 days No
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