Trial Outcomes & Findings for Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT02429375)
NCT ID: NCT02429375
Last Updated: 2022-05-12
Results Overview
For this objective the standard 3+3 dose-escalation scheme will be used. Patients will be accrued to the study in cohorts of 3 (starting with dose level 1). For any given dose an initial cohort of 3 patients will be treated at that dose. The dose level will be escalated if none of the 3 patients exhibits any DLT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
1 year
Results posted on
2022-05-12
Participant Flow
Participant milestones
| Measure |
Dose Level 1: 50mg Mocetinostat
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 2: 70mg Mocetinostat
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 3: 90mg Mocetinostat
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Dose Level 1: 50mg Mocetinostat
n=3 Participants
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 2: 70mg Mocetinostat
n=3 Participants
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 3: 90mg Mocetinostat
n=1 Participants
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
30 years
n=7 Participants
|
43 years
n=5 Participants
|
33 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data were not collected
For this objective the standard 3+3 dose-escalation scheme will be used. Patients will be accrued to the study in cohorts of 3 (starting with dose level 1). For any given dose an initial cohort of 3 patients will be treated at that dose. The dose level will be escalated if none of the 3 patients exhibits any DLT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35)
n=3 Participants
Patients with relapsed or refractory Hodgkin lymphoma will receive brentuximab vedotin combined with mocetinostat.
|
Dose Level 2: 70mg Mocetinostat
n=3 Participants
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 3: 90mg Mocetinostat
n=1 Participants
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
Progression of Disease
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
NA - Patient Withdrawal of Consent
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 1: 50mg Mocetinostat
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2: 70mg Mocetinostat
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3: 90mg Mocetinostat
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1: 50mg Mocetinostat
n=3 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 2: 70mg Mocetinostat
n=3 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 3: 90mg Mocetinostat
n=1 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Malaise
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
Other adverse events
| Measure |
Dose Level 1: 50mg Mocetinostat
n=3 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 2: 70mg Mocetinostat
n=3 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
Dose Level 3: 90mg Mocetinostat
n=1 participants at risk
Mocetinostat Plus Brentuximab Vedotin: All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
|
|---|---|---|---|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • 1 year
|
66.7%
2/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Fatigue
|
66.7%
2/3 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 1 year
|
100.0%
3/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
INR increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
Additional Information
Dr. Alison Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Phone: \646-608-3726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place