Trial Outcomes & Findings for ACY-1215 for Relapsed/Refractory Lymphoid Malignancies (NCT NCT02091063)
NCT ID: NCT02091063
Last Updated: 2024-08-06
Results Overview
This is designed to establish the safety of 2 dose schedules of ACY-1215 in patients with relapsed or refractory lymphoid malignancies treated with ACY-1215. If more than 1/3 or 2/6 patients experience a DLT in Phase I, there will be no expansion.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
ACY-1215: 160 mg Once Daily (Phase 1)
Cohort 1: Participants were administered ACY-1215 orally once a day for 28 days total.
|
ACY-1215: 160 mg Twice Daily (Phase 1)
Cohort 2: Participants were administered ACY-1215 orally twice a day for 28 days total.
|
ACY-1215: 160 mg Twice Daily (Expansion) (Phase 1)
Safety Expansion Cohort: Participants were administered ACY-1215 orally twice a day for 28 days total.
|
ACY-1215: 160 mg Twice Daily (Phase 2)
Participants were administered ACY-1215 orally twice a day for 28 days total.
|
|---|---|---|---|---|
|
Cohort 1: 160 mg Once Daily (Phase 1)
STARTED
|
3
|
0
|
0
|
0
|
|
Cohort 1: 160 mg Once Daily (Phase 1)
COMPLETED
|
3
|
0
|
0
|
0
|
|
Cohort 1: 160 mg Once Daily (Phase 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2: 160 mg Twice Daily (Phase 1)
STARTED
|
0
|
6
|
0
|
0
|
|
Cohort 2: 160 mg Twice Daily (Phase 1)
COMPLETED
|
0
|
6
|
0
|
0
|
|
Cohort 2: 160 mg Twice Daily (Phase 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Expansion: 160 mg Twice Daily (Phase 1)
STARTED
|
0
|
0
|
4
|
0
|
|
Expansion: 160 mg Twice Daily (Phase 1)
COMPLETED
|
0
|
0
|
4
|
0
|
|
Expansion: 160 mg Twice Daily (Phase 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
160 mg Twice Daily (Phase 2)
STARTED
|
0
|
0
|
0
|
8
|
|
160 mg Twice Daily (Phase 2)
COMPLETED
|
0
|
0
|
0
|
8
|
|
160 mg Twice Daily (Phase 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACY-1215 for Relapsed/Refractory Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
Includes participants treated with ACY-1215.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Disease type
Hodgkin's Lymphoma
|
7 Participants
n=5 Participants
|
|
Disease type
Diffuse large B-cell Lymphoma (DLBCL)
|
5 Participants
n=5 Participants
|
|
Disease type
T-cell Lymphoma
|
4 Participants
n=5 Participants
|
|
Disease type
Marginal Zone Lymphoma (MZL)
|
2 Participants
n=5 Participants
|
|
Disease type
Mantle Cell Lymphoma (MCL)
|
1 Participants
n=5 Participants
|
|
Disease type
Follicular Lymphoma
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Data was not collected due to early termination of study, therefore data cannot be analyzed or reported.
This is designed to establish the safety of 2 dose schedules of ACY-1215 in patients with relapsed or refractory lymphoid malignancies treated with ACY-1215. If more than 1/3 or 2/6 patients experience a DLT in Phase I, there will be no expansion.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected due to early termination of study, therefore data cannot be analyzed or reported.
The anti-tumor activity of ACY-1215 will be measured by the number of subjects with the response rate in Phase II: complete response \[CR\] and partial response \[PR\]. Complete Response (CR) - Disappearance of all non-target lesions by PET/CT. Nodal Mass: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative or (b) Variably FDG-avid or PET negative; regression to normal size on CT. Spleen/Liver: Not palpable, nodules disappeared. Partial Response (PR) - Regression of measurable disease and no new sites. Nodal Mass: 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes, (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen/Liver: 50% decrease in SPD of nodules.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=21 participants at risk
Includes participants treated with ACY-1215.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
4/21 • Number of events 4 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Confusion
|
19.0%
4/21 • Number of events 4 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
6/21 • Number of events 6 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Gastrointestinal disorders
Diarrhea
|
76.2%
16/21 • Number of events 16 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Fatigue
|
42.9%
9/21 • Number of events 9 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Nausea
|
61.9%
13/21 • Number of events 13 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Vomiting
|
38.1%
8/21 • Number of events 8 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Hepatobiliary disorders
Creatinine increased
|
23.8%
5/21 • Number of events 5 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
19.0%
4/21 • Number of events 4 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Anorexia
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Fever
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Headache
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
General disorders
Pain
|
42.9%
9/21 • Number of events 9 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
3/21 • Number of events 3 • 1 year
All adverse events were reported/collected from the study participants agnostic to their Arm assignment. Adverse events were NOT collected per dose level thus cannot be reported per dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place