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NMK36 late phase II. Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in patients with prostate cancer

NMK36 late phase II. Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in patients with prostate cancer

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In the safety analysis set, patient age [mean (standard deviation), and the same hereafter] was 67.3(6.0 )years, body weight was 65.46(7.58) kg , and PSA level was 88.6(168.42) ng/mL .

Seventy-two patients were enrolled for this study. The safety analysis set comprised 68 patients after excluding four who had either been withdrawn from the study before administration of NMK36 or who had not been administered NMK36. The full analysis set (FAS) from among the 68 patients in the safety analysis set was further divided into three by efficacy variable into the lymph node analysis set (FAS) 56 cases, bone metastasis analysis set (FAS) 66 cases, and primary tumour analysis set (FAS) 67 cases. Efficacy was evaluated in each of these.

Adverse events occurred in 6 of 68 patients (8.8%, 7 events) in this study. By symptom (PT), nasopharyngitis was seen in 3 patients (4.4%, 3 events), and white blood cell count increase, presence of glucose in urine, blood fibrinogen increase and presence of blood in urine were each seen in one patient (1.5%, 1 event each). Of these AEs, the only adverse reaction was 1 case (1.5%, 1 event) of blood fibrinogen increase. All AEs were non-serious, and severity was moderate (nasopharyngitis in 2 patients; 2 events) or mild. The two cases (2 events) of moderate nasopharyngitis resolved after treatment, and the other AEs resolved without treatment. There were no noteworthy significant abnormalities in laboratory values, vital signs or 12-lead ECG.

In terms of safety, it was concluded that in clinical use, prostate cancer patients would be able to tolerate a single intravenous dose of NMK36 containing a radioactivity dosage of 87MBq-270MBq (2 mL, 185MBq/2mL at time of calibration). In terms of efficacy, the analysis found that patient-based diagnostic accuracy for regional lymph node metastasis was 85.5% (47/55 cases) using NMK36-PET/CT (first run) and 87.3% (48/55 cases) using contrast CT as the control. These results were not significantly different.

Patient-based diagnostic accuracy of regional lymph node metastasis was 81.0% (34/42 cases) using NMK36-PET/CT (first run) and 83.3% (35/42 cases) using contrast CT in the radical prostatectomy group, and 100% (13/13 cases) for each method in the hormone therapy group. The concordance rate for presence of bone metastasis based on NMK36-PET/CT (first run) and existing diagnostic imaging and overall findings was 83.3% (55/66 cases). NMK36-PET/CT findings in the prostate were positive in 100% (67/67) of cases. In terms of the diagnostic accuracy of NMK36-PET/CT (first run) for patient-based regional lymph node metastasis, differences in the radioactivity dosage thus had little effect on regional lymph node visualisation. The diagnostic accuracy of NMK36-PET/CT imaging for patient-based regional lymph node metastasis was calculated in the patients for whom first run(up to 30 minutes after administration) and second run(from 30 to 60 minutes from administration) data were obtained. There was no difference between first run and second run diagnostic power.

In terms of efficacy, the diagnostic power for regional lymph node metastasis did not differ significantly between NMK36-PET/CT and contrast CT. In terms of safety, this method is tolerable in clinical use.

Jan. 04, 2016

https://pubmed.ncbi.nlm.nih.gov/26732384/

No

Nihon Medi-Physics Co., Ltd.

3-4-10, Shinsuna, Koto-ku, Tokyo 136-0075, Japan

Nihon Medi-Physics Co., Ltd.

3-4-10, Shinsuna, Koto-ku, Tokyo 136-0075, Japan

+81-3-5634-7363

completed

June. 27, 2012

Interventional

Non-randomized, open-label, uncontrolled

diagnostic purpose

2

-Patients with biopsy-proven prostate cancer.
-Patients who are to have radical prostatectomy or hormone treatment.

-Patients with treated prostate cancer.
-Patients with active double cancer.
-Patients with bone-marrow, hepatic or renal dysfunction.

Male

Prostate cancer

investigational material(s)
Generic name etc : fluciclovine(18F)
INN of investigational material : fluciclovine(18F)
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration for Investigational material : A single administration was performed of the whole contents of 1 vial of NMK36 (2 mL; 185 MBq/2 mL when calibrated).

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

safety
efficacy
Safety: subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests
Efficacy: diagnostic accuracy of regional lymph node metastases
-

efficacy
Efficacy: diagnostic performance of regional lymph node metastases, diagnostic performance of bone metastases, imaging performance of primary tumor, range of administered radioactivity, range of PET imaging time
-

April. 16, 2012