A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

Sponsors

Lead sponsor: Eisai Co., Ltd.

Source Eisai Inc.
Brief Summary

The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

Detailed Description

This is a multicenter, single-arm, open label, Phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of E7777 in participants with relapsed or refractory PTCL and CTCL.

Overall Status Completed
Start Date March 28, 2016
Completion Date April 24, 2019
Primary Completion Date April 24, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective Response Rate (ORR) From the date of beginning to the end of E7777 administration, or up to approximately 6 months
Secondary Outcome
Measure Time Frame
Progression Free Survival (PFS) From the date of beginning of E7777 administration to the date of first documentation of disease progression or death (whichever occurs first), or up to approximately 32 months
Duration of Response (DOR) From the date of first documentation of response to the end of response due to E7777 administration, or up to approximately 32 months
Time to Response (TTR) From the date of beginning of E7777 administration to the date of first document of response, or up to approximately 6 months
Complete Response (CR) Rate From the date of beginning to the end of E7777 administration, or up to approximately 6 months
Overall survival (OS) From the date of beginning of E7777 administration until date of death from any cause, or up to approximately 32 months
Enrollment 37
Condition
Intervention

Intervention type: Drug

Intervention name: E7777

Arm group label: E7777

Eligibility

Criteria:

Inclusion Criteria:

1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

2. Participant who have measurable disease.

3. Participant who had previous systemic chemotherapy.

4. Participant who had disease progression (PD) or did not have response (complete response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy.

5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

6. Participant with adequate renal, liver and bone marrow function.

7. Male and female participants ≥20 years of age at the time of informed consent.

8. Participants who have provided written consent to participate in the study.

Exclusion Criteria:

1. Participant with serious complications or histories.

2. Participant with history of hypersensitivity to protein therapeutics.

3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.

4. Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.

5. Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.

6. Woman who is pregnant or lactating.

7. Participant with allogeneic stem cell transplantation.

8. Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Eisai Trial Site #1 | Nagoya, Aichi, Japan
Eisai Trial Site #2 | Nagoya, Aichi, Japan
Eisai Trial Site #1 | Kashiwa, Chiba, Japan
Eisai Trial Site #1 | Ota, Gunma, Japan
Eisai Trial Site #1 | Kobe, Hyogo, Japan
Eisai Trial Site #1 | Tsukuba, Ibaraki, Japan
Eisai Trial Site #1 | Isehara, Kanagawa, Japan
Eisai Trial Site #1 | Sendai, Miyagi, Japan
Eisai Trial Site #1 | Kurashiki, Okayama, Japan
Eisai Trial Site #1 | Suita, Osaka, Japan
Eisai Trial Site #2 | Suita, Osaka, Japan
Eisai Trial Site #1 | Hamamatsu, Shizuoka, Japan
Eisai Trial Site #1 | Yamagata, Tamagata, Japan
Eisai Trial Site #1 | Bunkyo-ku, Tokyo, Japan
Eisai Trial Site #1 | Chuo-ku, Tokyo, Japan
Eisai Trial Site #1 | Koto-ku, Tokyo, Japan
Eisai Trial Site #1 | Fukuoka, Japan
Eisai Trial Site #1 | Kagoshima, Japan
Eisai Trial Site #1 | Kyoto, Japan
Eisai Trial Site #1 | Okayama, Japan
Location Countries

Japan

Verification Date

May 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: E7777

Arm group type: Experimental

Description: Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) will receive 9 μg/kg/day of E7777, administered by intravenous drip infusion in 60 minutes (± 10 min) for Days 1 through 5 of each cycle in maximum of 8 cycles. Every cycle consists of 3 weeks.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov