Trial Outcomes & Findings for SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma (NCT NCT02661022)
NCT ID: NCT02661022
Last Updated: 2024-04-17
Results Overview
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
For a 28-day cycle, Cycle 1
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
Phase 1, SL-401 7 µg/kg/Day
Phase 1, SL-401 7 µg/kg/day in combination with Pomalidomide and Dexamethasone
|
Phase 1, SL-401 9 µg/kg/Day
Phase 1, SL-401 9 µg/kg/day in combination with Pomalidomide and Dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Phase 1, SL-401 7 µg/kg/Day
Phase 1, SL-401 7 µg/kg/day in combination with Pomalidomide and Dexamethasone
|
Phase 1, SL-401 9 µg/kg/Day
Phase 1, SL-401 9 µg/kg/day in combination with Pomalidomide and Dexamethasone
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive Disease
|
2
|
1
|
Baseline Characteristics
SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
SL-401 7 µg/kg/Day
n=7 Participants
SL-401 7 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 7 µg/kg/day: SL-401 7 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
SL-401 9 µg/kg/Day
n=2 Participants
SL-401 9 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 9 µg/kg/day: SL-401 9 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 4.35 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 0.00 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 5.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Height
|
164.6 cm
STANDARD_DEVIATION 14.39 • n=5 Participants
|
164.7 cm
STANDARD_DEVIATION 6.65 • n=7 Participants
|
164.6 cm
STANDARD_DEVIATION 12.42 • n=5 Participants
|
|
Weight
|
85.6 kg
STANDARD_DEVIATION 18.40 • n=5 Participants
|
92.9 kg
STANDARD_DEVIATION 16.62 • n=7 Participants
|
87.2 kg
STANDARD_DEVIATION 17.29 • n=5 Participants
|
|
Eastern Cooperative Oncology Group Status (ECOG Status)
0
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Status (ECOG Status)
1
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Status (ECOG Status)
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For a 28-day cycle, Cycle 1To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma
Outcome measures
| Measure |
SL-401 7 µg/kg/Day
n=7 Participants
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
|
SL-401 9 µg/kg/Day
n=2 Participants
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
|
|---|---|---|
|
Number of Patients With Dose-limiting Toxicities and Treatment-emergent Adverse Events
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsTo evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma
Outcome measures
| Measure |
SL-401 7 µg/kg/Day
n=7 Participants
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
|
SL-401 9 µg/kg/Day
n=2 Participants
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
|
|---|---|---|
|
Number of Patients With Treatment-related Adverse Events
At Least 1 Treatment-Related Treatment-Emergent Adverse Event
|
7 Participants
|
2 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Fatigue
|
5 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Nausea
|
5 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Pyrexia
|
4 Participants
|
2 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Hypoalbuminaemia
|
4 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Chills
|
4 Participants
|
0 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Insomnia
|
3 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Aspartate aminotransferase increased
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Constipation
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Dizziness
|
3 Participants
|
0 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Flushing
|
3 Participants
|
0 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Headache
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Hypophosphataemia
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Neutropenia
|
3 Participants
|
0 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Oedema peripheral
|
3 Participants
|
0 Participants
|
|
Number of Patients With Treatment-related Adverse Events
Thrombocytopenia
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsTo evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM)
Outcome measures
| Measure |
SL-401 7 µg/kg/Day
n=7 Participants
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
|
SL-401 9 µg/kg/Day
n=2 Participants
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
|
|---|---|---|
|
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
At Least 1 TEAE Leading to Discontinuation of Study Drug
|
1 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
Capillary leak syndrome
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
Metastatic malignant melanoma
|
1 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
Pancreatitis
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug
Thrombocytopenia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 MonthsOverall response rate is defined as complete response + very good partial response + partial response and clinical benefit rate (CR + VGPR + PR + minimal response \[MR\]) based on International Myeloma Working Group-defined response criteria and the duration of response (DOR) in relapsed refractory multiple myeloma (RRMM) patients.
Outcome measures
| Measure |
SL-401 7 µg/kg/Day
n=5 Participants
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
|
SL-401 9 µg/kg/Day
n=1 Participants
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
|
|---|---|---|
|
Overall Response Rate
Overall Response Rate
|
5 Participants
|
0 Participants
|
|
Overall Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Stringent Complete Response
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Very Good Partial Response
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
5 Participants
|
0 Participants
|
|
Overall Response Rate
Minimal Response
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Stable Disease
|
0 Participants
|
1 Participants
|
|
Overall Response Rate
Progressive Disease
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Progressive Disease or Death After Overall Response
|
1 Participants
|
0 Participants
|
|
Overall Response Rate
Censored
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 MonthsPer International Myeloma Working Group Response Criteria, progression/progressive disease is defined as increase of \>25% from lowest response value in any 1 of the following: serum M-component (the absolute increase must be \>0.5 g/dL)4 and/or urine M-component (the absolute increase must be \>200 mg/24 h) and/or; only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL; only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels; bone marrow plasma cell percentage (absolute % must be ≥10%); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
SL-401 7 µg/kg/Day
n=5 Participants
SL-401 7 µg/kg/day in combination with pomalidomide and dexamethasone
|
SL-401 9 µg/kg/Day
n=1 Participants
SL-401 9 µg/kg/day in combination with pomalidomide and dexamethasone
|
|---|---|---|
|
Progression-free Survival
Disease Progression
|
1 Participants
|
0 Participants
|
|
Progression-free Survival
Death
|
0 Participants
|
0 Participants
|
|
Progression-free Survival
Censored
|
4 Participants
|
1 Participants
|
|
Progression-free Survival
PFS at 6 Months
|
4 Participants
|
0 Participants
|
|
Progression-free Survival
PFS at 12 Months
|
1 Participants
|
0 Participants
|
Adverse Events
SL-401 7 µg/kg/Day
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
SL-401 9 µg/kg/Day
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SL-401 7 µg/kg/Day
n=7 participants at risk
SL-401 7 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 7 µg/kg/day: SL-401 7 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
SL-401 9 µg/kg/Day
n=2 participants at risk
SL-401 9 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 9 µg/kg/day: SL-401 9 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
Other adverse events
| Measure |
SL-401 7 µg/kg/Day
n=7 participants at risk
SL-401 7 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 7 µg/kg/day: SL-401 7 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
SL-401 9 µg/kg/Day
n=2 participants at risk
SL-401 9 µg/kg/day in combination with Pomalidomide and Dexamethasone
SL-401 9 µg/kg/day: SL-401 9 µg/kg/day in combination with Pomalidomide/Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.9%
3/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Cardiac disorders
Bradycardia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Cardiac disorders
Tachycardia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Eye disorders
Hypermetropia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Eye disorders
Visual impairment
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Eye disorders
Vitreous floaters
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
General disorders
Asthenia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Chest discomfort
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Chills
|
71.4%
5/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Face oedema
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Fatigue
|
71.4%
5/7 • 12 months
|
100.0%
2/2 • 12 months
|
|
General disorders
Malaise
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Oedema
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Oedema peripheral
|
42.9%
3/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
General disorders
Pain
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
General disorders
Peripheral swelling
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
General disorders
Pyrexia
|
57.1%
4/7 • 12 months
|
100.0%
2/2 • 12 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Gastrointestinal viral infection
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Rhinitis
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
2/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Amylase increased
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Blood glucose increased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Glucose urine
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Lipase increased
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Red blood cell count decreased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Transaminases increased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Urine output decreased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Weight increased
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.6%
2/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
71.4%
5/7 • 12 months
|
100.0%
2/2 • 12 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
57.1%
4/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Nervous system disorders
Dizziness
|
57.1%
4/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • 12 months
|
100.0%
2/2 • 12 months
|
|
Nervous system disorders
Neuropathy peripheral
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Nervous system disorders
Restless legs syndrome
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Nervous system disorders
Tremor
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Psychiatric disorders
Emotional distress
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Psychiatric disorders
Insomnia
|
57.1%
4/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
42.9%
3/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
28.6%
2/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/7 • 12 months
|
50.0%
1/2 • 12 months
|
|
Vascular disorders
Flushing
|
42.9%
3/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • 12 months
|
0.00%
0/2 • 12 months
|
Additional Information
Ira Gupta, MD, Senior Vice President, Clinical Development & Medical Affairs - Hematology
Stemline Therapeutics, Inc.
Phone: 877-332-7967
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution's individual results may be submitted for publication only after the results of the multicenter study are published, 18 months after study completion at all sites, or notification from Stemline Therapeutics, Inc. that submission of a multicenter publication is no longer planned, whichever shall occur first.
- Publication restrictions are in place
Restriction type: OTHER