Clinical trial NCT02676778: Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Official title: A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Keywords: Peripheral T-cell lymphoma
Cutaneous T-cell lymphoma
E7777
Phase 2
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month
measure: Duration of Response (DOR)
timeFrame: From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month
measure: Time to Response (TTR)
timeFrame: From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month
measure: CR Rate
timeFrame: From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month
measure: Overall Survival (OS)
timeFrame: From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)
measure: Cmax: Maximum Observed Serum Concentration for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Tmax: Time to Reach the Cmax for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Mean Residence Time (MRT) for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: t1/2: Terminal Elimination Phase Half-life for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: CL: Total Clearance for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Vz: Volume of Distribution at Terminal Phase for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Vss: Volume of Distribution at Steady State for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Rac (Cmax): Accumulation Ratio of Cmax for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Rac (AUC): Accumulation Ratio of AUC for E7777
timeFrame: Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks)
measure: Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies
timeFrame: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
measure: Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody
timeFrame: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Eisai Trial Site #1
state: Aichi
city: Nagoya
country: Japan
facility: Eisai Trial Site #2
state: Aichi
city: Kashiwa
country: Japan
facility: Eisai Trial Site #1
state: Chiba
city: Ota
country: Japan
facility: Eisai Trial Site #1
state: Gunma
city: Kobe
country: Japan
facility: Eisai Trial Site #1
state: Hyogo
city: Tsukuba
country: Japan
facility: Eisai Trial Site #1
state: Ibaraki
city: Isehara
country: Japan
facility: Eisai Trial Site #1
state: Kanagawa
city: Sendai
country: Japan
facility: Eisai Trial Site #1
state: Miyagi
city: Kurashiki
country: Japan
facility: Eisai Trial Site #1
state: Okayama
city: Suita
country: Japan
facility: Eisai Trial Site #1
state: Osaka
city: Suita
country: Japan
facility: Eisai Trial Site #2
state: Osaka
city: Hamamatsu
country: Japan
facility: Eisai Trial Site #1
state: Shizuoka
city: Yamagata
country: Japan
facility: Eisai Trial Site #1
state: Tamagata
city: Bunkyo-ku
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Chuo-ku
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Koto-ku
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Fukuoka
country: Japan
facility: Eisai Trial Site #1
city: Kagoshima
country: Japan
facility: Eisai Trial Site #1
city: Kyoto
country: Japan
facility: Eisai Trial Site #1
city: Okayama
country: Japan
facility: Eisai Trial Site #1
Study officials:
References: