Trial Outcomes & Findings for Phase 2 Study of ONC201 in Neuroendocrine Tumors (NCT NCT03034200)
NCT ID: NCT03034200
Last Updated: 2024-11-26
Results Overview
Complete Response (CR) Disappearance or fibrosis of all target lesions. Any pathologic lymph nodes must have reduction in short axis to \<10mm and standardized uptake value (SUV) is \<4. Partial Response (PR) At least 30% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) and any decrease in SUV in Fludeoxyglucose 18F (18FDG) imaging Stable disease (SD) 0-29% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) or 0-19% increase in sum of longest diameters of target lesions (compared to initial on study baseline). SUV may increase or decrease Progressive disease 20% or more increase of sum of longest diameters of target lesions (compared to initial on study baseline). The sum must also be at an increase of at least 5mm or one or more new lesions that are considered metastatic disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 1 Year
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Arm A: Metastatic PC-PG
625mg ONC201 will be given once weekly
|
Arm B: Other NETs
625mg ONC201will be given once weekly
|
Arm C: PC-PG + Other NETs
625mg ONC201 will be given on day 1 and day 2 of each week
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
8
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
8
|
Reasons for withdrawal
| Measure |
Arm A: Metastatic PC-PG
625mg ONC201 will be given once weekly
|
Arm B: Other NETs
625mg ONC201will be given once weekly
|
Arm C: PC-PG + Other NETs
625mg ONC201 will be given on day 1 and day 2 of each week
|
|---|---|---|---|
|
Overall Study
Disease progression
|
8
|
10
|
4
|
|
Overall Study
Physician Decision
|
2
|
0
|
3
|
|
Overall Study
Patient off treatment for other complicating disease
|
0
|
1
|
0
|
|
Overall Study
Adjuvant Therapy
|
0
|
0
|
1
|
Baseline Characteristics
Phase 2 Study of ONC201 in Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Arm A: Metastatic PC-PG
n=10 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm B: Other NETs
n=12 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm C: PC-PG + Other NETs
n=8 Participants
625mg ONC201 will be given on day 1 and day 2 of each week
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
0-9 years of age
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
10-19 years of age
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Customized
20-29 years of age
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
30-39 years of age
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
40-49 years of age
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Customized
50-59 years of age
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
60-69 years of age
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
70-79 years of age
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 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
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearPopulation: All participants were analyzed.
Complete Response (CR) Disappearance or fibrosis of all target lesions. Any pathologic lymph nodes must have reduction in short axis to \<10mm and standardized uptake value (SUV) is \<4. Partial Response (PR) At least 30% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) and any decrease in SUV in Fludeoxyglucose 18F (18FDG) imaging Stable disease (SD) 0-29% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) or 0-19% increase in sum of longest diameters of target lesions (compared to initial on study baseline). SUV may increase or decrease Progressive disease 20% or more increase of sum of longest diameters of target lesions (compared to initial on study baseline). The sum must also be at an increase of at least 5mm or one or more new lesions that are considered metastatic disease
Outcome measures
| Measure |
Arm A: Metastatic PC-PG
n=10 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm B: Other NETs
n=12 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm C: PC-PG + Other NETs
n=8 Participants
625mg ONC201 will be given on day 1 and day 2 of each week
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
|---|---|---|---|
|
Tumor Response According to RECIST Criteria
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tumor Response According to RECIST Criteria
Partial Response (PR)
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Tumor Response According to RECIST Criteria
Stable Disease (SD)
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Tumor Response According to RECIST Criteria
Progressive disease
|
3 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants were analyzed for this outcome measure.
The median Duration of therapy was measured. Participants with stable disease + PR allowed to continue; participants with progression were taken off therapy.
Outcome measures
| Measure |
Arm A: Metastatic PC-PG
n=10 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm B: Other NETs
n=12 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm C: PC-PG + Other NETs
n=8 Participants
625mg ONC201 will be given on day 1 and day 2 of each week
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
|---|---|---|---|
|
Median Duration of Therapy
|
9 months
Interval 1.5 to 33.0
|
3 months
Interval 1.5 to 33.0
|
10 months
Interval 6.0 to 21.0
|
SECONDARY outcome
Timeframe: Up to 1 YearPopulation: All participants were analyzed.
Time from beginning of treatment until death, or one year, whichever comes first.
Outcome measures
| Measure |
Arm A: Metastatic PC-PG
n=10 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm B: Other NETs
n=12 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm C: PC-PG + Other NETs
n=8 Participants
625mg ONC201 will be given on day 1 and day 2 of each week
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
|---|---|---|---|
|
Overall Survival
|
4 Participants
|
4 Participants
|
7 Participants
|
POST_HOC outcome
Timeframe: 3 monthsPopulation: All participants were analyzed.
Participant performance status was measured using Karnofsky Performance Status Scale with the goal of determining the number of participants with a decline in score at 12 weeks. Karnofsky Performance Scale Index is an assessment tool for functional impairment. Scores can range from 0 to 100, with 100 indicating normal performance with no complaints or evidence of disease, while 0 indicates death.
Outcome measures
| Measure |
Arm A: Metastatic PC-PG
n=10 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm B: Other NETs
n=12 Participants
625mg ONC201 will be given once weekly
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
Arm C: PC-PG + Other NETs
n=8 Participants
625mg ONC201 will be given on day 1 and day 2 of each week
ONC201: 625mg ONC201 will be given on two consecutive days each week
|
|---|---|---|---|
|
Number of Participants With Decline in Karnofsky Performance Status
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Arm A: Metastatic PC-PG
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
Arm B: Other NETs
Serious events: 1 serious events
Other events: 1 other events
Deaths: 8 deaths
Arm C: PC-PG + Other NETs
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A: Metastatic PC-PG
n=10 participants at risk
625mg ONC201 will be given once weekly
|
Arm B: Other NETs
n=12 participants at risk
625mg ONC201will be given once weekly
|
Arm C: PC-PG + Other NETs
n=8 participants at risk
625mg ONC201 will be given on day 1 and day 2 of each week
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify: Abnormal EKG
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Pain
|
30.0%
3/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify: Gram positive infection
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Spinal cord compression
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Chills
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Edema face
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
Fever
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify - Hives
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Vascular disorders - Other, specify - Hemoptysis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify - High volume of bleeding
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify - Mechanical vent support
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Death NOS
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify - Exploratory laparotomy of abdomen
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Immune system disorders
Serum sickness
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
Other adverse events
| Measure |
Arm A: Metastatic PC-PG
n=10 participants at risk
625mg ONC201 will be given once weekly
|
Arm B: Other NETs
n=12 participants at risk
625mg ONC201will be given once weekly
|
Arm C: PC-PG + Other NETs
n=8 participants at risk
625mg ONC201 will be given on day 1 and day 2 of each week
|
|---|---|---|---|
|
Nervous system disorders
Spasticity
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Nervous system disorders
Brachial plexopathy
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Myopericarditis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Chills
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Nervous system disorders
Cognitive disturbance
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Investigations
Creatinine increased
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
37.5%
3/8 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Eye disorders
Dry Eye
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: Eustachian tube dysfunctin
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Fatigue
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Fever
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Neurogenic bowel
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify: Facial swelling
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify: Hives
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify: Neck swelling
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Vascular disorders
Hot flashes
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
30.0%
3/10 • 1 year
|
0.00%
0/12 • 1 year
|
62.5%
5/8 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
50.0%
4/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
50.0%
4/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
37.5%
3/8 • 1 year
|
|
Investigations
Investigations - Other, specify: Alkaline phosphatase decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Investigations - Other, specify: Aspartate aminotransferase decreased
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Hyperphosphatemia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Tube feed
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
37.5%
3/8 • 1 year
|
|
Nervous system disorders
Neuralgia
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
General disorders
Pain
|
30.0%
3/10 • 1 year
|
0.00%
0/12 • 1 year
|
37.5%
3/8 • 1 year
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
25.0%
2/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify: Dysthymia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Orthotopic bladder (neobladder)
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Contact dermatitis
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Vascular disorders
Vascular disorders - Other, specify: Diaphoresis
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
Additional Information
Dr. Peter Anderson
Cleveland Clinic Pediatric and Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-308-2706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place