Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02676778
Collaborator
(none)
45
20
1
36.9
2.3
0.1
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Actual Study Start Date
:
Mar 28, 2016
Actual Primary Completion Date
:
Apr 26, 2019
Actual Study Completion Date
:
Apr 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E7777 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. |
Drug: E7777
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [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]
ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
Secondary Outcome Measures
- Progression Free Survival (PFS) [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]
PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
- Duration of Response (DOR) [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]
DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. PD: Any new lesion or unequivocally increase of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method. Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
- Time to Response (TTR) [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]
TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee. PR or CR were assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). TTR was only conducted among responders who had experienced CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
- CR Rate [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]
CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee. CR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease.
- Overall Survival (OS) [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]
OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [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)]
- Cmax: Maximum Observed Serum Concentration for E7777 [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)]
- Tmax: Time to Reach the Cmax for E7777 [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)]
- AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 [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)]
- AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 [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)]
11 participants were included in the PK analysis, however AUC(0-inf), could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- Mean Residence Time (MRT) for E7777 [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)]
11 participants were included in the PK analysis, however MRT, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- t1/2: Terminal Elimination Phase Half-life for E7777 [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)]
11 participants were included in the PK analysis, however t1/2, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- CL: Total Clearance for E7777 [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)]
11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- Vz: Volume of Distribution at Terminal Phase for E7777 [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)]
11 participants were included in the PK analysis, however Vz, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- Vss: Volume of Distribution at Steady State for E7777 [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)]
11 participants were included in the PK analysis, however Vss, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
- Rac (Cmax): Accumulation Ratio of Cmax for E7777 [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)]
Accumulation Ratio of Cmax was calculated as RAC (Cmax) on Cycle 3 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1, and RAC (Cmax) on Cycle 5 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1.
- Rac (AUC): Accumulation Ratio of AUC for E7777 [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)]
Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1.
- Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies [Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)]
- Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody [Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
-
Participant who have measurable disease.
-
Participant who had previous systemic chemotherapy.
-
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.
-
Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
-
Participant with adequate renal, liver and bone marrow function.
-
Male and female participants ≥20 years of age at the time of informed consent.
-
Participants who have provided written consent to participate in the study.
Exclusion Criteria:
-
Participant with serious complications or histories.
-
Participant with history of hypersensitivity to protein therapeutics.
-
Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
-
Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
-
Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
-
Woman who is pregnant or lactating.
-
Participant with allogeneic stem cell transplantation.
-
Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eisai Trial Site #1 | Nagoya | Aichi | Japan | |
| 2 | Eisai Trial Site #2 | Nagoya | Aichi | Japan | |
| 3 | Eisai Trial Site #1 | Kashiwa | Chiba | Japan | |
| 4 | Eisai Trial Site #1 | Ota | Gunma | Japan | |
| 5 | Eisai Trial Site #1 | Kobe | Hyogo | Japan | |
| 6 | Eisai Trial Site #1 | Tsukuba | Ibaraki | Japan | |
| 7 | Eisai Trial Site #1 | Isehara | Kanagawa | Japan | |
| 8 | Eisai Trial Site #1 | Sendai | Miyagi | Japan | |
| 9 | Eisai Trial Site #1 | Kurashiki | Okayama | Japan | |
| 10 | Eisai Trial Site #1 | Suita | Osaka | Japan | |
| 11 | Eisai Trial Site #2 | Suita | Osaka | Japan | |
| 12 | Eisai Trial Site #1 | Hamamatsu | Shizuoka | Japan | |
| 13 | Eisai Trial Site #1 | Yamagata | Tamagata | Japan | |
| 14 | Eisai Trial Site #1 | Bunkyo-ku | Tokyo | Japan | |
| 15 | Eisai Trial Site #1 | Chuo-ku | Tokyo | Japan | |
| 16 | Eisai Trial Site #1 | Koto-ku | Tokyo | Japan | |
| 17 | Eisai Trial Site #1 | Fukuoka | Japan | ||
| 18 | Eisai Trial Site #1 | Kagoshima | Japan | ||
| 19 | Eisai Trial Site #1 | Kyoto | Japan | ||
| 20 | Eisai Trial Site #1 | Okayama | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02676778
Other Study ID Numbers:
- E7777-J081-205
First Posted:
Feb 8, 2016
Last Update Posted:
Jul 15, 2021
Last Verified:
Jun 1, 2021
Keywords provided by Eisai Co., Ltd.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 20 investigative sites in Japan from 28 March 2016 to 26 April 2019. |
|---|---|
| Pre-assignment Detail | A total of 45 participants were enrolled (obtained informed consent and screened), of these 8 were screen failures and 37 were treated. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) received E7777 9 microgram per kilogram per day (mcg/kg/day) as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length equal to [=] 3 weeks). | Participants with cutaneous T-cell lymphoma (CTCL) received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal natural killer (NK)/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Period Title: Overall Study | |||
| STARTED | 17 | 19 | 1 |
| COMPLETED | 0 | 7 | 0 |
| NOT COMPLETED | 17 | 12 | 1 |
Baseline Characteristics
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Total of all reporting groups |
| Overall Participants | 17 | 19 | 1 | 37 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
66.7
(9.16)
|
55.3
(15.09)
|
70.0
|
60.9
(13.63)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
5
29.4%
|
6
31.6%
|
1
100%
|
12
32.4%
|
| Male |
12
70.6%
|
13
68.4%
|
0
0%
|
25
67.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
17
100%
|
19
100%
|
1
100%
|
37
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Japanese |
17
100%
|
19
100%
|
1
100%
|
37
100%
|
Outcome Measures
| Title | Objective Response Rate (ORR) |
|---|---|
| Description | ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 0 |
| Number (95% Confidence Interval) [percentage of participants] |
41.2
242.4%
|
31.6
166.3%
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS was defined as a group of participants who received at least 1 dose of the study drug. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 0 |
| Median (95% Confidence Interval) [months] |
2.14
|
4.24
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. PD: Any new lesion or unequivocally increase of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method. Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here "overall number of participants analyzed" signifies responded participants. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 7 | 6 | 0 |
| Median (95% Confidence Interval) [months] |
3.09
|
4.83
|
| Title | Time to Response (TTR) |
|---|---|
| Description | TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee. PR or CR were assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). TTR was only conducted among responders who had experienced CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here "overall number of participants analyzed" signifies responded participants. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 7 | 6 | 0 |
| Median (Full Range) [months] |
1.28
|
2.12
|
| Title | CR Rate |
|---|---|
| Description | CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee. CR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS was defined as a group of participants who received at least 1 dose of the study drug. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 0 |
| Number (95% Confidence Interval) [percentage of participants] |
5.9
34.7%
|
0
0%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS was defined as a group of participants who received at least 1 dose of the study drug. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 0 |
| Median (95% Confidence Interval) [months] |
11.79
|
31.87
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 1 |
| TEAEs |
17
100%
|
19
100%
|
1
100%
|
| SAEs |
9
52.9%
|
8
42.1%
|
0
0%
|
| Title | Cmax: Maximum Observed Serum Concentration for E7777 |
|---|---|
| Description | |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic (PK) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
132
(43.1)
|
| Cycle 3 Day 1 |
142
(NA)
|
| Cycle 5 Day 1 |
140
(NA)
|
| Title | Tmax: Time to Reach the Cmax for E7777 |
|---|---|
| Description | |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
63.00
|
| Cycle 3 Day 1 |
65.00
|
| Cycle 5 Day 1 |
80.00
|
| Title | AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 |
|---|---|
| Description | |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
17600
(8040)
|
| Cycle 3 Day 1 |
15800
(NA)
|
| Cycle 5 Day 1 |
16500
(NA)
|
| Title | AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however AUC(0-inf), could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
23000
(7830)
|
| Cycle 5 Day 1 |
21400
(NA)
|
| Title | Mean Residence Time (MRT) for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however MRT, could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
136
(29.2)
|
| Cycle 5 Day 1 |
105
(NA)
|
| Title | t1/2: Terminal Elimination Phase Half-life for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however t1/2, could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
96.0
(19.6)
|
| Cycle 3 Day 1 |
116
(NA)
|
| Cycle 5 Day 1 |
69.2
(NA)
|
| Title | CL: Total Clearance for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
0.465
(0.250)
|
| Cycle 5 Day 1 |
0.421
(NA)
|
| Title | Vz: Volume of Distribution at Terminal Phase for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however Vz, could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
59.0
(17.4)
|
| Cycle 5 Day 1 |
42.0
(NA)
|
| Title | Vss: Volume of Distribution at Steady State for E7777 |
|---|---|
| Description | 11 participants were included in the PK analysis, however Vss, could not be estimated for 1 participant due to insufficient data for elimination rate constant. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 11 |
| Cycle 1 Day 1 |
57.4
(13.5)
|
| Cycle 5 Day 1 |
44.1
(NA)
|
| Title | Rac (Cmax): Accumulation Ratio of Cmax for E7777 |
|---|---|
| Description | Accumulation Ratio of Cmax was calculated as RAC (Cmax) on Cycle 3 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1, and RAC (Cmax) on Cycle 5 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1 |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 1 |
| Cycle 3 Day 1 |
0.993
(NA)
|
| Cycle 5 Day 1 |
0.979
(NA)
|
| Title | Rac (AUC): Accumulation Ratio of AUC for E7777 |
|---|---|
| Description | Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK analysis set: group of participants who received at least 1 dose of study drug with at least 1 serum concentration data, and included participants who had taken frequent blood sampling for non-compartment analysis. Overall number of participants analyzed is number of participants with evaluable data at Cycle 1 Day 1 and at Cycles 3 and 5 Day 1 |
| Arm/Group Title | PTCL and CTCL Participants: E7777 9 mcg/kg/Day |
|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL and CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 1 |
| Cycle 5 Day 1 |
0.827
(NA)
|
| Title | Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies |
|---|---|
| Description | |
| Time Frame | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacodynamics (PD) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 1 |
| Anti-E7777 antibody: Cycle 1 Day 1 |
11
64.7%
|
13
68.4%
|
1
100%
|
| Anti-E7777 antibody: Cycle 2 Day 1 |
5
29.4%
|
11
57.9%
|
0
0%
|
| Anti-E7777 antibody: Cycle 3 Day 1 |
3
17.6%
|
11
57.9%
|
|
| Anti-E7777 antibody: Cycle 5 Day 1 |
1
5.9%
|
10
52.6%
|
|
| Anti-E7777 antibody: Cycle 8 Day 1 |
7
41.2%
|
||
| Anti-E7777 antibody: Discontinuation/Completion |
10
58.8%
|
15
78.9%
|
1
100%
|
| Anti-IL-2 antibody: Cycle 1 Day 1 |
1
5.9%
|
1
5.3%
|
0
0%
|
| Anti-IL-2 antibody: Cycle 2 Day 1 |
2
11.8%
|
4
21.1%
|
0
0%
|
| Anti-IL-2 antibody: Cycle 3 Day 1 |
2
11.8%
|
11
57.9%
|
|
| Anti-IL-2 antibody: Cycle 5 Day 1 |
1
5.9%
|
10
52.6%
|
|
| Anti-IL-2 antibody: Cycle 8 Day 1 |
7
41.2%
|
||
| Anti-IL-2 antibody: Discontinuation/Completion |
3
17.6%
|
15
78.9%
|
0
0%
|
| Title | Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody |
|---|---|
| Description | |
| Time Frame | Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PD analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment. |
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day |
|---|---|---|---|
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). |
| Measure Participants | 17 | 19 | 1 |
| Cycle 1 Day 1 |
0
0%
|
0
0%
|
0
0%
|
| Cycle 2 Day 1 |
2
11.8%
|
9
47.4%
|
0
0%
|
| Cycle 3 Day 1 |
2
11.8%
|
11
57.9%
|
|
| Cycle 5 Day 1 |
1
5.9%
|
8
42.1%
|
|
| Cycle 8 Day 1 |
6
35.3%
|
||
| Discontinuation/Completion |
8
47.1%
|
12
63.2%
|
0
0%
|
Adverse Events
| Time Frame | 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) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day | |||
| Arm/Group Description | Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks). | |||
All Cause Mortality |
||||||
| PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
Serious Adverse Events |
||||||
| PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/17 (52.9%) | 8/19 (42.1%) | 0/1 (0%) | |||
| Blood and lymphatic system disorders | ||||||
| Lymphopenia | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Lymphadenopathy | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Thrombocytopenia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| General disorders | ||||||
| Pyrexia | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic function abnormal | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Infections and infestations | ||||||
| Cytomegalovirus chorioretinitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Herpes zoster | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Pneumonia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 4/17 (23.5%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Aspartate aminotransferase increased | 4/17 (23.5%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Rhabdomyolysis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Squamous cell carcinoma of skin | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Tumour associated fever | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Nervous system disorders | ||||||
| Altered state of consciousness | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Peripheral sensory neuropathy | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Laryngeal haemorrhage | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Drug eruption | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Vascular disorders | ||||||
| Capillary leak syndrome | 0/17 (0%) | 4/19 (21.1%) | 0/1 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| PTCL: E7777 9 mcg/kg/Day | CTCL: E7777 9 mcg/kg/Day | Other: E7777 9 mcg/kg/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/17 (100%) | 19/19 (100%) | 1/1 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Lymphopenia | 14/17 (82.4%) | 11/19 (57.9%) | 1/1 (100%) | |||
| Thrombocytopenia | 9/17 (52.9%) | 3/19 (15.8%) | 1/1 (100%) | |||
| Anaemia | 3/17 (17.6%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Leukocytosis | 0/17 (0%) | 4/19 (21.1%) | 0/1 (0%) | |||
| Leukopenia | 4/17 (23.5%) | 0/19 (0%) | 0/1 (0%) | |||
| Neutropenia | 2/17 (11.8%) | 0/19 (0%) | 0/1 (0%) | |||
| Lymphocytosis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Thrombocytosis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Cardiac disorders | ||||||
| Cardiomegaly | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Sinus bradycardia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Sinus tachycardia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Supraventricular extrasystoles | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Ventricular arrhythmia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Hypoacusis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Endocrine disorders | ||||||
| Adrenal insufficiency | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Hypothyroidism | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Eye disorders | ||||||
| Eye pain | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Conjunctivitis allergic | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Disorder of orbit | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Dry eye | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Eczema eyelids | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Photopsia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Retinal exudates | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Vision blurred | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 4/17 (23.5%) | 10/19 (52.6%) | 0/1 (0%) | |||
| Nausea | 5/17 (29.4%) | 6/19 (31.6%) | 0/1 (0%) | |||
| Vomiting | 4/17 (23.5%) | 3/19 (15.8%) | 0/1 (0%) | |||
| Diarrhoea | 2/17 (11.8%) | 0/19 (0%) | 1/1 (100%) | |||
| Stomatitis | 2/17 (11.8%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Abdominal discomfort | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Abdominal pain upper | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Ascites | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Colitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Dyspepsia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Dysphagia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Gingival pain | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Haemorrhoids | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Mouth ulceration | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Perianal erythema | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Toothache | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| General disorders | ||||||
| Pyrexia | 9/17 (52.9%) | 7/19 (36.8%) | 1/1 (100%) | |||
| Malaise | 4/17 (23.5%) | 8/19 (42.1%) | 0/1 (0%) | |||
| Oedema peripheral | 5/17 (29.4%) | 3/19 (15.8%) | 0/1 (0%) | |||
| Fatigue | 3/17 (17.6%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Generalised oedema | 0/17 (0%) | 3/19 (15.8%) | 0/1 (0%) | |||
| Face oedema | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Facial pain | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Injection site erythema | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Pain | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Puncture site pain | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Vessel puncture site erythema | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic function abnormal | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Immune system disorders | ||||||
| Contrast media allergy | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Drug hypersensitivity | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Infections and infestations | ||||||
| Angular cheilitis | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Lung infection | 2/17 (11.8%) | 0/19 (0%) | 0/1 (0%) | |||
| Cellulitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Conjunctivitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Cytomegalovirus chorioretinitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Cytomegalovirus infection | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Enterocolitis infectious | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Folliculitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Gastroenteritis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Genital candidiasis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Gingivitis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Herpes virus infection | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Impetigo | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Nasopharyngitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Parotitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Pneumonia | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Skin candida | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Skin infection | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Tinea pedis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Upper respiratory tract infection | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Wound infection | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Wound | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Investigations | ||||||
| Aspartate aminotransferase increased | 13/17 (76.5%) | 15/19 (78.9%) | 1/1 (100%) | |||
| Alanine aminotransferase increased | 13/17 (76.5%) | 15/19 (78.9%) | 0/1 (0%) | |||
| Gamma-glutamyltransferase increased | 9/17 (52.9%) | 7/19 (36.8%) | 1/1 (100%) | |||
| Lipase increased | 6/17 (35.3%) | 4/19 (21.1%) | 0/1 (0%) | |||
| Weight increased | 4/17 (23.5%) | 3/19 (15.8%) | 0/1 (0%) | |||
| Blood alkaline phosphatase increased | 2/17 (11.8%) | 3/19 (15.8%) | 1/1 (100%) | |||
| Amylase increased | 3/17 (17.6%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Blood cholesterol increased | 3/17 (17.6%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Blood lactate dehydrogenase increased | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Blood creatine phosphokinase increased | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| C-reactive protein increased | 0/17 (0%) | 1/19 (5.3%) | 1/1 (100%) | |||
| Weight decreased | 2/17 (11.8%) | 0/19 (0%) | 0/1 (0%) | |||
| Blood bilirubin increased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Blood creatinine increased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Blood fibrinogen decreased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Blood urea increased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Brain natriuretic peptide increased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Cytomegalovirus test positive | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Electrocardiogram QT prolonged | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| N-terminal prohormone brain natriuretic peptide increased | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypoalbuminaemia | 12/17 (70.6%) | 14/19 (73.7%) | 0/1 (0%) | |||
| Decreased appetite | 5/17 (29.4%) | 5/19 (26.3%) | 1/1 (100%) | |||
| Hypertriglyceridaemia | 5/17 (29.4%) | 5/19 (26.3%) | 0/1 (0%) | |||
| Hyperglycaemia | 2/17 (11.8%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Hyponatraemia | 3/17 (17.6%) | 0/19 (0%) | 1/1 (100%) | |||
| Dehydration | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Hypokalaemia | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Hypophosphataemia | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Hyperkalaemia | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Hyperuricaemia | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Dyslipidaemia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Hypocalcaemia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Tumour lysis syndrome | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Myalgia | 0/17 (0%) | 4/19 (21.1%) | 0/1 (0%) | |||
| Back pain | 0/17 (0%) | 2/19 (10.5%) | 1/1 (100%) | |||
| Arthralgia | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Muscle spasms | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Musculoskeletal stiffness | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Rhabdomyolysis | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumour associated fever | 2/17 (11.8%) | 0/19 (0%) | 0/1 (0%) | |||
| Cancer pain | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Tumour pain | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Nervous system disorders | ||||||
| Dysgeusia | 3/17 (17.6%) | 0/19 (0%) | 0/1 (0%) | |||
| Headache | 1/17 (5.9%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Dizziness | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Peripheral sensory neuropathy | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Post herpetic neuralgia | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 3/17 (17.6%) | 4/19 (21.1%) | 0/1 (0%) | |||
| Delirium | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Hallucination, auditory | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Renal and urinary disorders | ||||||
| Proteinuria | 2/17 (11.8%) | 1/19 (5.3%) | 1/1 (100%) | |||
| Renal impairment | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Prostatic pain | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Oropharyngeal pain | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Cough | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Hiccups | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Laryngeal pain | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Pharyngeal inflammation | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Upper respiratory tract inflammation | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis exfoliative generalised | 1/17 (5.9%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Pruritus | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Skin erosion | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Dermal cyst | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Dermatitis contact | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Dermatosis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Rash | 0/17 (0%) | 0/19 (0%) | 1/1 (100%) | |||
| Rash generalised | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
| Skin fissures | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Skin ulcer | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Toxic skin eruption | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Vascular disorders | ||||||
| Hypertension | 1/17 (5.9%) | 4/19 (21.1%) | 0/1 (0%) | |||
| Capillary leak syndrome | 0/17 (0%) | 3/19 (15.8%) | 0/1 (0%) | |||
| Hot flush | 0/17 (0%) | 2/19 (10.5%) | 0/1 (0%) | |||
| Hypotension | 0/17 (0%) | 1/19 (5.3%) | 0/1 (0%) | |||
| Vasculitis | 1/17 (5.9%) | 0/19 (0%) | 0/1 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Inquiry Service. |
|---|---|
| Organization | Eisai Co., Ltd. |
| Phone | |
| eisai-chiken_hotline@hhc.eisai.co.jp |
Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02676778
Other Study ID Numbers:
- E7777-J081-205
First Posted:
Feb 8, 2016
Last Update Posted:
Jul 15, 2021
Last Verified:
Jun 1, 2021