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Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

13

Overall(Phase1 part), the median age was 64.0 years (range: 23 to 75 years) and 8 of 13 subjects (61.5%) were male. All subjects were Japanese in this study. The median height and weight were 161.10 cm (range: 143.9 to 175.2 cm) and 56.60 kg (45.1 to 73.1 kg), respectively. Overall, 10 PTCL subjects (76.9%; in narrow definition of PTCL) and 3 CTCL subjects (23.1%) were administered E7777 in this study and the baseline ECOG performance status were either 0 or 1. Phase 1b part was not conducted in this study.

Fifteen subjects were screened for entry into the study. Of these 15 subjects, 2 (13.3%) were screening failures and 13 (86.7%) were confirmed to be eligible to continue in the study. All of the 13 subjects (10 PTCL and 3 CTCL subjects) received E7777 at 6 ug/kg/day (3 subjects), 9 ug/kg/day (7 subjects), or 12 ug/kg/day (3 subjects), and included in the Safety Analysis Set, the Efficacy Analysis Set, the PK Analysis Set, and the PD Analysis Set.

All of 13 subjects experienced at least one TEAE. The most frequently reported TEAEs (>=50.0%) were alanine aminotransferase increased (12 subjects; 92.3%), aspartate aminotransferase increased, decreased appetite, fatigue (11 subjects each; 84.6%), hypoalbuminemia, lymphocyte count decreased (10 subjects each; 76.9%), nausea (9 subjects; 69.2%), platelet count decreased (8 subjects; 61.5%), constipation, hypertriglyceridemia, and leukocytosis (7 subjects each; 53.8%).

No DLT was observed in 6 ug/kg/day group. All of 3 subjects in 12 ug/kg/day group experienced DLTs. Thus 12 ug/kg/day was judged not to be tolerated. Two in 6 subjects experienced DLTs in 9 ug/kg/day. The MTD and RD was judged to be 9 ug/kg/day.

Overall, 5 of 13 subjects (38.5%) had PR, 3 subjects (23.1%) had SD, 4 subjects (30.8%) had PD, and 1 subject had NE as their best overall response. Tumor response (PR) was observed in 4 of 10 PTCL subjects regardless of the level of CD25 expression in tumors as well as 1 of 3 CTCL subjects. ORR was 38.5% (exact 95% CI: 13.9%, 68.4%) and DCR was 61.5% (exact 95% CI: 31.6%, 86.1%) overall.

The MTD and RD was judged to be 9 ug/kg/day.

Feb. 26, 2018

https://www.ncbi.nlm.nih.gov/pubmed/29363235?dopt=Abstract

Yes

https://www.eisai.com/company/business/research/clinical/index.html

Eisai Co., Ltd.

医療関係者：https://inquiry.eisai.co.jp/webapp/form/17713_hfab_2/index.do,

Eisai Co., Ltd.

医療関係者：https://inquiry.eisai.co.jp/webapp/form/17713_hfab_2/index.do,

completed

June. 27, 2011

Interventional

Open Label

treatment purpose

1

-Male and female patients 20 to less than 80 years of age at the time of informed consent
-Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
-Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
-No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)

Brain metastasis with clinical symptoms which requires treatment
Serious systemic infection requiring intensive treatment
Serious complications or histories
History of hypersensitivity to protein therapeutics
Known to be positive for HIV antibody, HCV antibody, or HBs antigen
History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
Patients who have undergone allogeneic hematopoietic stem cell transplantation
Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation

Both

Peripheral T-Cell Lymphoma

investigational material(s)
Generic name etc : E7777
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous (IV) infusion

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

safety
other
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)

safety
efficacy
pharmacokinetics
-

-

June. 23, 2011