Trial Outcomes & Findings for Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001 (NCT NCT01226472)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

one year

Results posted on

2024-04-25

Participant milestones
Measure	KW-0761 KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	KW-0761 KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Overall Study Progressive Disease	1

Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Baseline characteristics by cohort
Measure	KW-0761 n=1 Participants KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White, Hispanic or Latino	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

Timeframe: one year

Population: Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).

Outcome measures
Measure	KW-0761 n=1 Participants KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging Progression-Free Survival (PFS)	260 days
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging Time to Progression (TTP)	260 days
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging Duration of Overall Response (DR)	232 days

Timeframe: one year

Outcome measures
Measure	KW-0761 n=1 Participants KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any TEAE	1 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any Drug-related TEAE	0 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any TEAE with an Outcome of Death	0 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any Serious TEAE	0 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any Drug-related Serious TEAE	0 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability. With Any Serious TEAE with an Outcome of Death	0 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	KW-0761 n=1 participants at risk KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Metabolism and nutrition disorders Hypophosphataemia	100.0% 1/1 • Number of events 2

Phone: 609-919-1100

Restriction type: GT60