Trial Outcomes & Findings for Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas (NCT NCT02341014)
NCT ID: NCT02341014
Last Updated: 2024-04-04
Results Overview
Determine the MTD by NCI-CTCAE v4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
21 days
Results posted on
2024-04-04
Participant Flow
Participant milestones
| Measure |
Phase Ib: DL 1
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 3
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 4
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (56 mg/m2 IV)
|
Phase IIa - MTD
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
0
|
0
|
14
|
|
Overall Study
COMPLETED
|
6
|
6
|
0
|
0
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase Ib: DL 1
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 3
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 4
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (56 mg/m2 IV)
|
Phase IIa - MTD
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas
Baseline characteristics by cohort
| Measure |
Phase Ib: DL 1
n=6 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 3
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 4
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (56 mg/m2 IV)
|
Phase IIa - MTD
n=14 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
67 years
n=7 Participants
|
—
|
—
|
56 years
n=21 Participants
|
57 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
—
|
12 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
—
|
11 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
—
|
13 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
—
|
14 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Phase Ib participants
Determine the MTD by NCI-CTCAE v4.0.
Outcome measures
| Measure |
Phase Ib: DL 1
n=6 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase IIa - MTD
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|
|
Maximum Tolerated Dose of Romidepsin
|
8 mg/m^2 romidepsin
|
8 mg/m^2 romidepsin
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Phase Ib participants
Determine the MTD by NCI-CTCAE v4.0.
Outcome measures
| Measure |
Phase Ib: DL 1
n=6 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase IIa - MTD
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|
|
Maximum Tolerated Dose of Lenalidomide
|
15 mg of Lenalidomide
|
15 mg of Lenalidomide
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Phase Ib participants
Determine the MTD by NCI-CTCAE v4.0.
Outcome measures
| Measure |
Phase Ib: DL 1
n=6 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase IIa - MTD
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|
|
Maximum Tolerated Dose of Carfilzomib
|
36 mg/m^2 of Carfilzomib
|
36 mg/m^2 of Carfilzomib
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: T-cell Lymphoma participants evaluable for response at the maximum tolerated dose
will be summarized using percentages and confidence intervals will be provided. ORR will be calculated based on the best response at any time during the course of treatment on this protocol.
Outcome measures
| Measure |
Phase Ib: DL 1
n=6 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase IIa - MTD
n=14 Participants
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|
|
Overall Response Rate (Orr) at the Maximum Tolerated Dose
|
50 percentage of pts with response
Interval 12.0 to 88.0
|
57 percentage of pts with response
Interval 18.0 to 90.0
|
42 percentage of pts with response
Interval 15.0 to 72.0
|
Adverse Events
Phase Ib: DL 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 4 deaths
Phase Ib: DL 2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase Ib: DL 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase Ib: DL 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase IIa - MTD
Serious events: 3 serious events
Other events: 5 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Phase Ib: DL 1
n=6 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 3
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 4
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (56 mg/m2 IV)
|
Phase IIa - MTD
n=14 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
General disorders
Chills
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
General disorders
Death NOS
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
General disorders
Edema
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
General disorders
Fever
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
28.6%
2/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
2/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Investigations
Thrombocytopenia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
Other adverse events
| Measure |
Phase Ib: DL 1
n=6 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
Phase Ib: DL 2
n=7 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 3
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (45 mg/m2 IV)
|
Phase Ib: DL 4
Romidepsin (10mg/m2 IV) + Lenalidomide (20mg PO, QD) + Carfilzomib (56 mg/m2 IV)
|
Phase IIa - MTD
n=14 participants at risk
Romidepsin (8mg/m2 IV) + Lenalidomide (15mg PO, QD) + Carfilzomib (36 mg/m2 IV)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
28.6%
2/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
42.9%
3/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
2/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
28.6%
2/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
57.1%
4/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
2/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
14.3%
1/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
0.00%
0/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
|
Investigations
Weight loss
|
0.00%
0/6 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
28.6%
2/7 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
—
0/0 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
7.1%
1/14 • 1 year
Participants were not enrolled on Dose Level/DL 3 and DL4.
|
Additional Information
Dr. Steve Horwitz, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place