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A phase III study of PALO in pediatric patients receiving highly and moderately emetogenic chemotherapy.

PALO Pediatric clinical study in Japan

60

The most frequently reported cancer types were acute lymphocytic leukemia in 17 patients (29.3%) and retinoblastoma and rhabdomyosarcoma in 10 patients each (17.2%).

From December 2016 to June 2019, 60 patients were enrolled, and 58 received at least one dose of palonosetron.

Although AEs of any grade and grade >= 3 occurred in 51 patients (87.9%) and 46 patients (79.3%), respectively, most AEs were considered to have been caused by concomitant anticancer drugs. Treatment-related AEs (TRAEs) of any grade and grade >= 3 occurred in two patients (3.4%) and one patient (1.7%), respectively (Table 4). However, all TRAEs were reported to be recovering during the study period. No new TRAEs occurred in Course 2 or later. There were no serious TRAEs, AEs leading to discontinuation of treatment or treatment-related deaths during the study period.

The proportion of patients achieving a CR during the overall phase in Course 1 was 58.6% (95% CI, 44.9%-71.4%), showing that the primary endpoint was met with the lower limit of 95% CI in excess of the 30% threshold (P < 0.0001).

By age group, the proportions of patients achieving a CR during the overall phase in Course 1 were 64.3%, 61.1%, 50.0% and 57.1% in Groups A, B, C and D, respectively, with good efficacy in all groups. In Step 2, the proportions of patients achieving a CR during the overall phase after multiple courses were 71.4% (5/7), 33.3% (1/3) and 0.0% (0/1) in Courses 2, 3 and 4, respectively. The results of the secondary endpoints in Course 1 were as follows. The proportions of patients achieving a CR were 72.4% and 63.8% during the acute and delayed phases, respectively. During the acute, delayed and overall phases, the proportions of patients with no vomiting were 79.3%, 74.1% and 65.5%, respectively; the proportions of patients with no emetic episodes were 72.4%, 65.5% and 58.6%, respectively; the proportions of patients without rescue medication use were 93.1%, 87.9% and 87.9%, respectively; and the proportions of patients with no nausea (aged >=6 years) were 50.0%, 42.3% and 34.6%, respectively.

This study has demonstrated the substantial efficacy of PALO at 20 micro g/kg, administered intravenously as single or multiple courses for CINV (including delayed phase) in combination with DEX, in pediatric patients receiving HEC or MEC.

May. 21, 2021

https://academic.oup.com/jjco/article/51/8/1204/6279902?login=true

No

https://www.clinicaltrials.jp/file/yksdFTTdd

Taiho Pharmaceutical Co., Ltd.

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toiawaseCD1@taiho.co.jp

Taiho Pharmaceutical Co., Ltd.

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-

toiawase@taiho.co.jp

completed

Dec. 01, 2016

Interventional

A multicenter, open-label, uncontrolled study

prevention purpose

3

1. Patients aged from 28 days after birth to 18 years
2. Patients weight at least 3.2 kg
3. Patients with malignant disease who are scheduled to receive initial chemotherapy (excluding multi-day administration) including the Cisplatin, Carboplatin or Cyclophosphamide.

1. Patients scheduled to receive stem cell rescue therapy together with the cancer chemotherapy.

Both

Chemotherapy induced nausea and vomiting

investigational material(s)
Generic name etc : PALO
INN of investigational material : Palonosetron
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : PALO 20 ug/kg (maximum dose of 1.50 mg) once daily intravenous infusion

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

efficacy
Efficacy:complete response (defined as no vomiting, no retching and no use of antiemetic rescue medication)

safety
pharmacokinetics
Safety
Pharmacokinetics

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Nov. 29, 2016