Trial Outcomes & Findings for Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets (NCT NCT01581307)
NCT ID: NCT01581307
Last Updated: 2017-03-03
Results Overview
OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 29 months
Results posted on
2017-03-03
Participant Flow
Participants were enrolled at Moffitt Cancer Center June 2012 through March 2014.
Participant milestones
| Measure |
2nd Line Chemotherapy With Radiotherapy
Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every two weeks for 6-10 cycles.
The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.
TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
2nd Line Chemotherapy With Radiotherapy
Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every two weeks for 6-10 cycles.
The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.
TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets
Baseline characteristics by cohort
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=9 Participants
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
70.44 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 29 monthsPopulation: All participants evaluable at time of analysis
OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.
Outcome measures
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=8 Participants
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Median Overall Survival (OS)
|
14.09 months
Interval 1.379 to 27.79
|
SECONDARY outcome
Timeframe: Up to 29 monthsPopulation: All participants evaluable at time of analysis
PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.
Outcome measures
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=8 Participants
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Rate of Progression Free Survival (PFS)
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 29 monthsPopulation: All participants evaluable at time of analysis
The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.
Outcome measures
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=7 Participants
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
5 Participants
|
Adverse Events
2nd Line Chemotherapy With Radiotherapy
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=9 participants at risk
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 5 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
3/9 • Number of events 6 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Gastric ulcer
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - melena
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 4 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Death NOS
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Abdominal infection
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Biliary tract infection
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
Other adverse events
| Measure |
2nd Line Chemotherapy With Radiotherapy
n=9 participants at risk
Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
4/9 • Number of events 14 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Chest pain - cardiac
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
3/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Eye disorders
Watering eyes
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain
|
77.8%
7/9 • Number of events 14 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Bloating
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9 • Number of events 5 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Gastric ulcer
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - stool color changes
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 6 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 5 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
3/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
3/9 • Number of events 5 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Number of events 4 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 10 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Chills
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
General disorders and administration site conditions - Other, thrush
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, jaundice
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Abdominal infection
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Biliary tract infection
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Infections and infestations
Lung infection
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Lymphocyte count decreased
|
88.9%
8/9 • Number of events 36 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
6/9 • Number of events 7 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
3/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
INR increased
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Weight loss
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Weight gain
|
11.1%
1/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Blood bilirubin increased
|
33.3%
3/9 • Number of events 6 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Neutrophil count decreased
|
77.8%
7/9 • Number of events 13 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Platelet count decreased
|
66.7%
6/9 • Number of events 17 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
White blood cell decreased
|
77.8%
7/9 • Number of events 23 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Investigations
Investigations - Other, Prothrombin time increased
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Anorexia
|
44.4%
4/9 • Number of events 7 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
4/9 • Number of events 15 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
55.6%
5/9 • Number of events 18 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
3/9 • Number of events 6 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
3/9 • Number of events 9 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
77.8%
7/9 • Number of events 23 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, muscle cramps
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Dizziness
|
44.4%
4/9 • Number of events 5 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 4 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
44.4%
4/9 • Number of events 4 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Renal and urinary disorders
Urinary tract pain
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, discoloration
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • Number of events 1 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • Number of events 3 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • 30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
|
Additional Information
Dr. Sarah Hoffe
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place