Trial Outcomes & Findings for Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations (NCT NCT03047213)
NCT ID: NCT03047213
Last Updated: 2025-12-01
Results Overview
Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria. In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 4 weeks after last dose of study treatment (approximately 19 weeks)
Results posted on
2025-12-01
Participant Flow
Participant milestones
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
TSC Mutation 2
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
3
|
|
Overall Study
COMPLETED
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
TSC Mutation 2
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
Baseline characteristics by cohort
| Measure |
TSC Mutation 2
n=3 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
Total
n=17 Participants
Total of all reporting groups
|
Treatment (Sapanisertib): TSC Mutation 1
n=14 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=122 Participants
|
67 years
n=243 Participants
|
68.5 years
n=121 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=122 Participants
|
16 Participants
n=243 Participants
|
13 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
12 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
10 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=122 Participants
|
17 participants
n=243 Participants
|
14 participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0
|
1 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
5 Participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
1
|
2 Participants
n=122 Participants
|
9 Participants
n=243 Participants
|
7 Participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
2
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
2 Participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
3
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
4
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
5
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=121 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after last dose of study treatment (approximately 19 weeks)Population: 12 of 14 patients were evaluable for the outcome.
Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria. In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|
|
Overall Response Rate (TSC1 Patients)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of study treatment (approximately 19 weeks)Presented are the most frequently occurring adverse events (25% of patients or greater)
Outcome measures
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|
|
Incidence of Toxicity (TSC1 Patients)
urinary tract infection
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
vomiting
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
weight loss
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Hyperglycemia
|
11 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Creatinine increased
|
7 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Hypoalbuminemia
|
7 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Anemia
|
6 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
AST increased
|
5 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
diarrhea
|
5 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
lymphocyte count decreased
|
5 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
rash
|
5 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Alkaline phosphatase increased
|
4 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Abdominal pain
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Anorexia
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Fatigue
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Hyperkalemia
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
hypomagnesemia
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
Hypophosphatemia
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
nausea
|
3 Participants
|
|
Incidence of Toxicity (TSC1 Patients)
platelet count decreased
|
3 Participants
|
SECONDARY outcome
Timeframe: Time from start of treatment to date of progression or death- (approximately 19 weeks)Population: 12 of 14 patients were evaluable
The censored PFS distributions will each be estimated by the Kaplan-Meier (K-M) survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc. Upon results entry, no patients had reached 6 or 12 months PFS and the outcome and timeframe have been updated. Progression-free survival (PFS) is defined as the duration of time from start of treatment to date of progression or death, whichever occurs first. Progression by RECIST v1.1 criteria is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|
|
Progression-free Survival (PFS) (TSC1 Patients)
|
54 days
Interval 10.0 to 127.0
|
SECONDARY outcome
Timeframe: Time from start of treatment to time of death from any cause, up to approximately 9 monthsPopulation: 12 of 14 patients were evaluable
The censored OS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc.
Outcome measures
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|
|
Overall Survival (OS) (TSC1 Patients)
|
114 days
Interval 32.0 to 192.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks after last dose of study treatment (approximately 19 weeks)Outcome measures
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=3 Participants
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|
|
Overall Response Rate (TSC2 Patients)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks after last dose of study treatmentThe occurrence rate of each specific type of toxicity at a certain severity grade will be described by point estimates and Wilson type 90% (2-sided) CIs.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from start of treatment to date of progression or death, whichever occurs first, assessed up to 1 yearThe censored PFS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from start of treatment to time of death from any cause, assessed up to 1 yearThe censored OS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Sapanisertib): TSC Mutation 1
Serious events: 6 serious events
Other events: 12 other events
Deaths: 10 deaths
TSC Mutation 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 participants at risk
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
TSC Mutation 2
n=3 participants at risk
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|---|
|
Renal and urinary disorders
Creatinine increased
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Blood and lymphatic system disorders
platelet count decreased
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
AKI
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
dehydration
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
constipation
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
bowel obstruction
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
GI hemorrhage
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness lower limb
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Nervous system disorders
syncope
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
urinary tract obstruction
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Hepatobiliary disorders
ALT increased
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Hepatobiliary disorders
AST increase
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Infections and infestations
urinary tract injection
|
0.00%
0/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Infections and infestations
sepsis
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
Other adverse events
| Measure |
Treatment (Sapanisertib): TSC Mutation 1
n=12 participants at risk
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
TSC Mutation 2
n=3 participants at risk
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sapanisertib: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Investigations
Activated PTT prolonged
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
AKI
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
33.3%
4/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Hepatobiliary disorders
ALT increased
|
8.3%
1/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
6/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Hepatobiliary disorders
AST increased
|
41.7%
5/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
8.3%
1/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Gastrointestinal disorders
bowel obstruction
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
Chills
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Cholesterol high
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
constipation
|
8.3%
1/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
Creatinine increased
|
58.3%
7/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
dehydration
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
diarrhea
|
41.7%
5/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Nervous system disorders
drop foot
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
edema
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
General disorders
Edema limbs
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Eye disorders
Eye pain
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
Fatigue
|
25.0%
3/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Infections and infestations
fever
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
General disorders
Flank pain
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
GI hemorrhage
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Psychiatric disorders
Hallucination
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
hypercalcemia
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
91.7%
11/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
3/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
8.3%
1/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
58.3%
7/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
3/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Vascular disorders
hypotension
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Investigations
INR increased
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Psychiatric disorders
insomnia
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Investigations
lipase increase
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
41.7%
5/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
malaise
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Gastrointestinal disorders
mucositis oral
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness lower limb
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
nausea
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
non-cardiac chest pain
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
pain
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Blood and lymphatic system disorders
platelet count decreased
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Renal and urinary disorders
proteinuria
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
pruritus
|
16.7%
2/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
rash
|
41.7%
5/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Infections and infestations
sepsis
|
0.00%
0/12 • Up to 9 months
|
33.3%
1/3 • Up to 9 months
|
|
Cardiac disorders
sinus bradycardia
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Nervous system disorders
syncope
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Infections and infestations
urinary tract infection
|
25.0%
3/12 • Up to 9 months
|
66.7%
2/3 • Up to 9 months
|
|
Renal and urinary disorders
urinary tract obstruction
|
8.3%
1/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
General disorders
vomiting
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
|
Metabolism and nutrition disorders
weight loss
|
25.0%
3/12 • Up to 9 months
|
0.00%
0/3 • Up to 9 months
|
Additional Information
Joseph Kim, MD, Associate Professor of Internal Medicine
Yale School of Medicine: Medical Oncology
Phone: (203) 200-4822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60